Distal wire stop

ABSTRACT

A method and apparatus for releasably securing a wire guide to an elongate medical device for introduction into a work site with the bodily lumen of a patient. An elongate engagement member is configured to engage the wire guide while it is coupled to the elongate medical device and is configured so as to prevent relative movement between the wire guide and the elongate medical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. Non-Provisionalapplication Ser. No. 10,901,561, filed Jul. 29, 2004, which claimspriority to U.S. Provisional Applications Ser. No. 60/570,656, filed May13, 2004, Ser. No. 60/563,968, filed Apr. 21, 2004, and Ser. No.60/491,408, filed Jul. 31, 2003.

TECHNICAL FIELD

This invention relates to medical devices, more particularly cathetersand the like that are introduced into the patient over a wire guide.

BACKGROUND OF THE INVENTION

Minimally invasive medicine, the practice of gaining access into a bloodvessel, duct, or organ using a wire guide to facilitate the subsequentintroduction or placement of catheters and other medical devices, hasbeen evolving since the Seldinger technique was first popularized duringthe late 1950s and 1960s. A significant advance was gaining the abilityto exchange medical devices over a single indwelling wire guide withoutrequiring displacement of the wire in the process and loss of access tothe site. This ‘over the wire’ (OTW) exchange technique requires anextra long guide wire so that control over the wire could be maintainedat all times during the procedure. To accomplish this, the portion ofthe wire extending out of the patient must be at least as long as thedevice itself so that a proximal portion of the wire could be secured atall times maintain longitudinal positioning, typically by an assistantstanding well behind the physician. For example, endoscopic cathetersthat are used to access the biliary system are typically 200 cm or morein length, requiring a wire guide of more than 400 cm (e.g., 480 cm) tobe long enough to remain in the duct during the exchange. To remove thecatheter over the wire, the physician and an assistant must carefullymake a series of well-coordinated, one to one movements between theexchange wire and device. The assistant pushes the wire the same amountas the physician pulls back on the catheter until the device iscompletely outside of the patient and the physician gains control overthe wire at the port of the scope. The assistant then pulls the deviceoff of the wire such that a second device can be fed back over the wireand into the patient to perform a second operation, requiring the samepush-pull technique in reverse. This procedure requires a well-trainedassistant, who actually is responsible for the advancement of the wire,instead of the physician. In biliary ERCP, this lack of wire guidecontrol can be a disadvantage when cannulating the ampullary orificebecause the techniques used are typically highly dependent on goodverbal communication between the physician and assistant, and theexperience of the latter.

Although the ‘long wire’ or OTW technique still remains a commonly usedmethod of exchanging devices in the biliary system, a technique wasdeveloped which allowed for a much shorter wire guide and more physiciancontrol over the wire. Variously known as the ‘rapid exchange,’‘monorail,’ or ‘short-wire’ technique, it differs from the OTW techniquein that instead of the device being introduced over the length of thewire guide, the wire guide is coupled for only a portion of the lengthof the catheter device. The device is fed over the wire guide, whichthen exits the passageway or a coupling portion of the catheter at apoint between the catheter's distal end and the proximal portion via aport or channel formed in the side of the catheter, typically locatedwithin the distal portion of the device. This allows the physician tohave control of the proximal or external portion of the wire at alltimes as it exits the patient or scope and reduces the need forcoordinating device movements with an assistant. When the coupledportion exits the patient (or endoscope in the case ofgastroenterological or other endoscopic procedures), the physicianperforms a short exchange (instead of the traditional long-wireexchange, which in biliary procedures, requires the assistant to standwell out of the sterile field in order to assist with the exchange).With certain other devices, the catheter is split or torn away touncouple it from the wire as the catheter exits the patient. Tointroduce the device, the coupled portion of the catheter is advancedover the proximal end of the wire guide, while the physician is carefulto maintain the wire in position so that its distal end is maintainedwithin the work site and access is not lost.

Rapid exchange or short wire techniques have proven particularlydesirable in coronary and vascular medicine whereby it is common for asequence of procedures using multiple catheter-based devices to beperformed over a single wire, such as stent placement followingangioplasty. Another example of where short wire exchange techniques areoften used is in endoscopic procedures performed in the pacreatobiliarysystem. Typically, an ERCP (endoscopic retrogradecholangiopancreatography) procedure is performed by introducing acatheter device from a duodenoscope through the ampullary orifice(Papilla of Vater) and into the biliary tree, which includes the bileduct, pancreatic duct, and hepatic ducts of the liver. The cannulationdevice, which typically comprises a sphincterotome/papillotome or ECRPcatheter, is introduced into the biliary tree to perform a firstoperation, which could be diagnostic in nature, such as injectingcontrast media, or for therapeutic purposes, such as enlarging theampullary orifice. When a second medical operation is required, such asto remove a stone, open a stricture, sample tissue, etc., a second orperipheral device, e.g., balloon, basket, snare, biopsy brush, dilator,stent delivery catheter, etc., can be introduced over the original wireguide to perform a secondary therapeutic procedure.

While OTW techniques have permitted the exchange of devices, thedevelopment of short wire techniques has found acceptance by physicianswho prefer to maintain greater control of the wire guide at the scope.Well-known examples of this rapid exchange technology are the devicescomprising the MICROVASIVE RX BILIARY SYSTEM™ (Boston ScientificCorporation, Natwick, Mass.) in which the catheter portion of thedevices include an internal lumen extending between a distal opening anda proximal side opening spaced 5-30 cm therefrom, depending on thedevice, thereby requiring an exchange of that length as the device isbeing removed over the 260 cm JAGWIRE® Guidewire guide developed forthat system. An example of a sphincterotome of this system (AUTOTOME™Cannulating Sphincterotome) is depicted in FIG. 1. Extending proximallyfrom the proximal side opening, the lumen forms a ‘C-channel’ (shown inFIG. 2) that holds the wire guide within the catheter as the catheterportion is introduced into the scope, but allows the wire to belaterally pulled out of the channel to gain access of the wire at thebiopsy port of the scope as the catheter is being removed from the scope(FIG. 3), so that a second catheter type device (e.g., balloon, basket,stent delivery catheter, etc.) can be subsequently fed over the proximalend of the wire. As the distal portion of the first device is exitingthe scope, a short exchange is required (coordinated push-pull movementsbetween the physician and assistant) that is similar in practice to thatused in an OTW procedure, until the physician gains control of the wireand the assistant can pull off the first device without risking loss ofaccess. The proximal end of the wire guide is typically secured to thescope during much of the procedure to prevent loss of access, but itmust be disengaged from the scope to allow the exchange and removal ofthe catheter.

While the Microvasive system has offered modest time savings, morephysician control of the wire, and placed less reliance on the skill ofthe assistant to help perform the exchange, a short exchange procedureis still required in which care must be taken to prevent loss of wireguide access to the duct, particularly since the wire guide cannot besecured to the scope during removal of the catheter. Because the wireguide resides in the channel of the catheter and the coupled devices areconstrained together in the accessory channel, uncoupling must takeplace as the distal portion of the catheter exits the proximal end ofthe scope. The process is further slowed by the frictional resistancebetween the wire and catheter, which remains a problem in subsequentexchanges as devices are fed or removed over the wire residing in thecatheter lumen or C-channel.

Having a C-channel extending along the catheter can result in certainclinical disadvantages. For example, the split in the catheter providesan entry point for blood and bile, a known source of viruses andbacteria, to enter the catheter lumen and migrate to the proximal end ofthe device where they typically leak out onto the floor and clothing ofthose involved in the procedure. The channel also represents a point ofpotential air leakage, which can compromise the ability to maintainadequate insufflation within the duodenum during the procedure. Anotherdisadvantage of a C-channel is that it degrades the integrity of thecatheter, which can be problematic in a cannulating device (such as adeflecting Sphincterotome) when attempting to push through or ‘lift’ thepapilla to straighten the entry pathway into the duct, or when pushingthrough a stricture.

The current rapid exchange or short wire system also fails to addresssome of the shortcomings found in the traditional OTW method. Forexample, recannulation of the papilla is required when placing multipleplastic drainage stents side by side since the delivery system must beremoved to disconnect the wire. Furthermore, existing devices do notoffer the ability to place a second wire guide after the first one, suchas to place stents in multiple ducts, since the catheter, which couldotherwise serve as a conduit, must be removed from the patient and worksite before it would have a free lumen for a second wire. Anotherdisadvantage of current systems for exchanging biliary devices is theincompatibility between the two systems. Long wire devices lack the sideaccess port for use with a short exchange wire and the MICROVASIVE RXBILIARY SYSTEM™ devices with C-channels are poorly configured for longwire exchange since once the C-channel has been breached during thefirst exchange, it is difficult to introduce a long wire through theproximal wire guide access port (which includes the open channel) andkeep it from slipping from the channel as it is being introduced.Further, the C-channel is typically not compatible with smaller-diameterwire guides (less than 0.035″) for the same reason. Incompatibilitybetween systems means that physicians cannot take advantage of all ofthe choices available when selecting the best device and treatment for aparticular patient.

What is needed is an improved short-wire system and technique forefficiently and reliably exchanging devices within a work site which iscompatible with long wire exchange method and which addresses the otherdeficiencies described above.

SUMMARY OF THE INVENTION

The foregoing problems are solved and a technical advance is achieved inan illustrative system and method for introducing and exchangingmultiple elongate medical devices, e.g., tubular members such ascatheters and the like, over an indwelling guiding member, such as awire guide, within a patient by remotely uncoupling the first device(primary access device) from the guiding member within the work site(defined as a lumen, duct, organ, vessel, other bodily passage orcavity, or the pathway leading thereto in which wire guide/guidingmember access is maintained throughout a particular procedure or seriesof procedures), thereby facilitating the removal of the device andsimplifying introduction of a secondary access device over theindwelling wire without an exchange of devices taking place outside ofthe patient. While the primary focus of this application is the exchangeof devices within the pancreatobiliary system or elsewhere in thegastrointestinal tract, the system and method of remote uncoupling ofdevices within a work site can be adapted for any part of the body toperform any suitable procedure where the exchange of devices takes placeover an indwelling guiding member. Examples include, but are not limitedto the introduction and placement of balloons, stents, grafts,occluders, filters, distal protection devices, catheters for ablation,phototherapy, brachytherapy etc., prosthetic valves, or otherinstrumentation or devices into the vascular system, including thecoronary arteries, peripheral arterial system (e.g., carotid or renalarteries), or venous system (e.g., the deep veins of the legs). Otherexemplary sites include the genito-urinary system (e.g., bladder,ureters, kidneys, fallopian tubes, etc.), and the bronchial system.Additionally, the present system and method can be used for exchangingdevices within body cavities, e.g., the peritoneum, pleural space,pseudocysts, or true cystic structures, via percutaneous placement andexchange through a needle, trocar, or sheath.

The basic system of devices for remote uncoupling comprises a guidingmember, typically a wire guide. It should be understood that hereafter,the term ‘wire guide’ is used in the specification in a generic sense toinclude any device (e.g., small-diameter catheter, laser fiber, string,plastic beading, stylet, needle etc.) configured to perform the samefunction, although such a device technically may not be considered awire guide (or ‘guidewire’) as the term is most commonly used in themedical arts. Remote uncoupling permits a shorter guiding member/wireguide to be used than for other short wire methods (e.g., rapidexchange), and thus hereafter, the methods described in thisspecification are referred to collectively as the ‘ultra-short wire’technique, or depending on the work site, ‘intraductal exchange’ (IDE),‘intravascular exchange’ (IVE), etc. The reason that the wire guide canbe of a shorter length than traditional rapid exchange wire guides isthat there is no exchange outside the patient. In fact, remoteuncoupling allows for the exchange wire guide to be shorter than thedevices being introduced since the devices are not removed over thewire. For example, the wire guide of the present inventive system ofbiliary devices (for use in a 145 cm channel duodenoscope) is typically185 cm (minimum functional length of about 180 cm), as opposed to the260 cm wire guide typically used for the Microvasive ‘rapid exchange’procedures in which a 5 to 30 cm external exchange must be performedeach time, depending on the device used. The shorter wire is easier tomanipulate by a single operator and helps prevent it from contactingnon-sterile surfaces, such as the floor, patient bed, instrument table,imaging unit, etc. The 185 cm length still permits most external changesto be performed, if necessary. To accommodate a longer wire forexchanging a device otherwise not compatible with the system, anoptional coupling mechanism on the proximal end of the wire can beincluded to engage a wire guide extender portion to lengthen the wire(e.g., to 260 or 480 cm) and permit a traditional exchange to takeplace.

Coupled to the guiding member/wire guide is a first elongate medicaldevice (the primary access device), typically a tubular member orcatheter device, which includes a coupling region, such as a passagewayor lumen, external channel, outer ring, or other interface area, locatedabout the distal portion and which is configured to receive a portion ofthe wire guide such that both devices can comprise a releasably coupledpair while operating within a work site. The coupling region may be anintegral part of the elongate medical device or may located about aseparate element disposed therewith (e.g., an elongate engagmentmember), which for purposes of this application is considered part ofthe elongate medical device. A separate elongate engagement member canprovide a primary or secondary means of releasably securing the wireguide and catheter device until they are to be repositioned oruncoupled. The elongate engagement member, typically but not necessarilydisposed within the passageway of the tubular member, can furthercomprise the coupling region as well. Preferably, the primary accessdevices used with this system have a closed or self-sealing passagewayextending to the proximal (external) portion of the device (instead ofan open or split channel) such that the system can be readily convertedto introduce a long wire if a long wire-compatible device is selected.Further, the devices of this invention are configured for traditionalshort wire exchange back over the wire, if so desired, or when remoteuncoupling becomes problematic (e.g., due to unexpected anatomicalconstraints).

In a first aspect of the invention, the system further includes analignment indicator system, such as a system of indicia (e.g.,radiopaque markers, external markings, endoscopic markings, etc.)located about the wire guide and/or first elongate medical device thatcan be utilized by the operator in locating the position of the distalend or distal portion of the wire guide relative to the proximal end ofthe coupling region, such as at a side access port or aperture (e.g.,scive) through which the wire exits. The alignment indication systemadvantageously allows the physician to control when the two devices arecoupled or uncoupled within the work site and helps provide confirmationthat uncoupling has occurred. Without the ability to receive suchconfirmation, it would be extremely difficult for the physician toattempt, with any confidence, the uncoupling of the catheter from thewire guide (e.g., under fluoroscopic guidance) without knowing whenuncoupling has occurred or is about to occur. Depending on the locationor work site within the body and the device being delivered, an attemptto ‘blindly’ uncouple devices can lead to loss of wire guide access,especially if the device is prematurely withdrawn with the wire guidestill engaged. Furthermore, the amount of relative movement between thedevice and the wire guide required to ensure that uncoupling hadoccurred would generally be much greater than if indicia were utilized,thus increasing risks such as the wire guide being withdrawn too far andaccess lost or encountering situations where there is insufficient spacewithin the work site left for uncoupling to take place. Typical rapidexchange devices are not configured with the necessary radiographic orother appropriate indicia since the exchange procedure is intended totake place outside of the patient. The external exchange is a slowerprocess and dictates removal of the first catheter before anothercatheter or wire guide can be advanced to the work site over an existingdevice (which always must be a wire guide or guiding device intraditional rapid exchange).

A first series of embodiments of the system of indicia includesradiographic or ultrasonically reflective markings located about one ormore of the devices which are used by the operator under an appropriateexternal guidance system (fluoroscopy, MRI, CT scan, x-ray, ultrasound,etc.) to determine the state of alignment and engagement between theprimary or secondary access device and guiding device. A first examplecomprises radiopaque or high-density bands, markings, etc., located onthe distal portions of the wire guide and first elongate medical device.In particular, the distal tip of the wire guide includes a radiopaqueportion that typically comprises at least the length of the couplingregion of the first elongate medical device, which itself includes aradiopaque marker, such as a band comprising iridium, platinum, or othersuitable material, located about the proximal end of the coupling region(e.g., at, or just distal to the side access port), thus allowing theoperator to know when the distal tip of the wire is nearing or hasexited the point of the catheter at which the devices become uncoupledor separate within the work site. Additionally, other radiopaque markersmay be present that are generally not used to assist in remoteuncoupling, such as at the distal end of the catheter or indicia usedfor stent or balloon placement.

A second series of embodiments of the system indicia comprises directlyviewable indicia located about the proximal portions of the wire guideand the tubular member to which it is coupled during the procedure. Inone example, the wire guide comprises a visually distinctive alignmentpoint, such as a single mark (e.g., colored band) or a transition pointbetween different colored and/or patterned regions of the wire guideouter coating, which when aligned with a specified first marking on theproximal portion of the elongate medical device, indicates that thedistal ends of the wire guide and tubular member are in alignment withrespect to one another. The catheter further includes a second mark thatrepresents the disengagement point, that when aligned with thedesignated alignment marking of the wire guide, is indicative that thetwo devices are about to or have uncoupled or disengaged with the distaltip of the wire guide having exited the coupling region. Preferably, thefirst (distal) and second (proximal) markings on the proximal portion ofthe catheter are located within a region that remains external of thepatient or scope during a procedure and are spaced apart by the samedistance as the length of the coupling region. For very short couplingregions (e.g., rings), a single mark on the catheter may be preferableto indicate disengagement, if proximal indicia are to be used.

A third series of embodiments of the system of indicia include markingsthat are configured to be viewable by a fiberoptic endoscope orvideoendoscope (e.g., duodenoscope, gastroscope, bronchoscope,ureteroscope, etc.). In devices configured for accessing thepancreatobiliary system, the indicia comprise a marking located on boththe wire guide and elongate medical device disposed within anintermediate portion of each, which is typically located distal to theviewing lens or video chip of the scope, but proximal to the ampullaryorifice during a typical procedure, such that they can be aligned byusing the video monitor (or viewing port) to ascertain that uncouplingwithin the duct has occurred. The device may include other endoscopicindicia useful during the remote uncoupling procedure. For example, abiliary catheter may include a depth marking at a designated distancefrom the catheter tip (e.g., 10 cm) which when buried within thepapilla, indicates that IDE can be performed safely within the ductwithout risking loss of wire guide access. Furthermore, the distalportion of the wire guide can be distinctive in appearance (e.g., black)as a visual cue to warn the physician if the tip is in danger of pullingcompletely out of the duct, which would require recannulation of thepapilla. The second and third system of indicia do not require externalimaging, thus the physician can advantageously limit the time that thepatient is exposed to fluoroscopy. For example, fluoroscopy can be usedonly at selected, critical times during the procedure with at least oneof the other types or indicia being used elsewhere for alignmentguidance.

In addition to the use of visual indicia to confirm whether the wireguide and first elongate medical device (and subsequent devices) areengaged or uncoupled, the present invention includes other types ofalignment indication systems, such as a tactile system that includes oneor more protuberances and/or indentations along one or more of thedevices or the endoscope accessory channel port to allow the physicianto ‘feel’ or sense the point where disengagement has occurred or isimminent due to the discrete point(s) of increased resistance betweenthe device as they move relative to one another. Magnets can be a partof a tactile system as well. Other embodiments of the alignmentindicator system include sensor-based systems in which a sensor locatedwithin the system, such as along the catheter or endoscope channel/port,detects a calibrated location elsewhere in the system (e.g., the wireguide or catheter) and emits or provides a signal or cue (e.g.,electrical signal) that is relayed to the operator in the form of anaudio or visual alert that warns the operator that the devices have orare about to become uncoupled. The alignment system can comprise asingle system or means for alignment, or any combination of visual andnon-visual indicators.

In a second aspect of the invention, a method is provided for uncouplingthe first elongate medical device from the wire guide while both arestill dwelling within the work site (i.e., the basic ultra-short wiretechnique). Both devices are introduced into the work site, using astandard introduction method and introducer member such as an endoscope,introducer sheath, etc., with the wire guide engaged through thecoupling region of the medical device being introduced. In oneembodiment for use in the pancreatobiliary system, the coupling regioncomprises a passageway within the distal portion of the catheter, suchas the distal 6 cm thereof, with the wire guide exiting at that pointthrough a side access port (e.g., scive) such that the wire guidecoextends along the outside of the proximal portion of the catheter asboth reside side by side along the introduction pathway, which in thebiliary embodiment comprises the channel of the duodenoscope. Forexample, 4 a wire guide or primary access device, such as asphincterotome, needle knife, ERCP catheter, etc., may be introducedfirst to cannulate the duct, with the primary access device beingsubsequently advanced over the wire to perform a first medical operationthat is diagnostic and/or therapeutic in nature. During this time, thewire guide is preferably secured in place by attaching the proximalportion to the endoscope via a locking device, clip, other means locatedabout wire guide entry port (biopsy port), thus fixing its positionlongitudinally to assist with maintaining access to the work site. Oncethe first device has performed its intended operation (inject contrastmedia, ablate the sphincter, etc.), the operator preferably uses theradiographic, endoscopic, and/or proximal system of indica to providevisual guidance during repositioning of the devices to permitdisengagement. One technique (referred to herein as ‘device IDE’)includes advancing the primary access device over the stationary wireguide until uncoupling has occurred. A second technique (referred toherein as ‘wire guide IDE’) includes withdrawing the wire guide whilemaintaining the primary access device in a stationary position until thealignment indicia indicates that uncoupling has occurred. A thirdtechnique would involve a combination of the device and wire guide IDE.Also, there typically is a characteristic ‘whipping’ action of theradiopaque wire guide tip portion upon exit from the passageway that isviewable under fluoroscopy which also provides a visually distinctiveindicator of uncoupling.

When the physician, using at least one component of the alignmentindicator system, has determined that the tip of the wire guide hasdisengaged from the coupling region of the primary access device, thefirst device can be easily removed by merely pulling it back out of theendoscope accessory channel (or introducer sheath in the case ofvascular or certain other non-endoscopic applications). Removal isgreatly facilitated by the elimination of friction which would haveotherwise existed between the wire guide and catheter if the wireresided within the channel or lumen. Although some of the aforementionedMICROVASIVE RX™ biliary devices (e.g., the AUTOTOME™ sphincterotome)include a side port within the distal portion, all of the devices lackthe combination of indicia that make a remote or intraductal exchangeclinically practical or even possible. Furthermore, those devices thatinclude an open channel extending proximally of the side access portcannot be uncoupled within the duct or work site regardless of the lackof indicia since the proximal portion of the wire guide tends to ‘seek’and reenter the channel when both devices are residing within theaccessory channel of the scope. Thus, remote disconnection is renderedimpossible without some means to releasably disengage the wire from thechannel.

After the catheter and wire guide are uncoupled, the proximal end of thewire is available for a third elongate medical device (e.g., a secondaryaccess device or a second device that is the same as the first) to beadvanced thereover to the work site. In one example of the method, theproximal end of the indwelling wire is fed through the distal openingand out of the side access port of the secondary device, which is thenadvanced to the work site. If after the second medical operation usingthe secondary device, another secondary device is required for anotheroperation, the first secondary device (third medical device) is removedfrom the wire guide and the patient, and the wire guide is available toprovide access for a fourth device in the same manner as the first two.

In a variation of the present method, the primary access device may beleft in place at the work site after disengagement with the wire guideto serve as an introduction pathway or conduit for a second wire guide,such as for a procedure where two branches of a duct or vessel are to becannulated. An example of such a procedure is when a stent must beplaced in two different ducts draining separate lobes of the liver. Thesecond wire guide is typically introduced through a proximal wire guideport or hub of the first device, typically disposed about the handleportion, the port communicating with the passageway. This techniquetypically requires a long-wire exchange of the catheter. A second optionis to introduce the wire through a proximal side access port (e.g., ascive) formed through the wall of the tubular member so that fullcontrol of the wire is maintained. In this embodiment, the catheterwalls are configured to be splittable between the proximal and sideaccess ports, or include an open or self-sealing channel through whichthe wire guide can be stripped out toward the distal portion of thedevice such that a long exchange is not required. Removing or strippingthe wire guide laterally from the passageway can be done by anywell-known means, such as scoring or structurally weakening a wall ofthe catheter, using a splittable, isotropically oriented catheter wallmaterial (e.g., PTFE), incorporating a sealable or locking seamtherealong, or by thinning the wall and/or using a material that allowsthe wire guide to split the wall and form its own exit pathway whensufficient force is supplied. Alternatively, a wire guide that includesa coupling region, such as an attached sleeve, can be used to couple toa standard wire guide that is already indwelling, or both wires can becoupled together and advanced through the passageway of the elongatetubular member.

After gaining access to the passageway by one of the aforementionedroutes, the wire guide is guided under external imaging, such asfluoroscopy, into the desired location. Optionally, if the first deviceis a sphincterotome or other type of deflectable catheter, the operatorcan manipulate the shape and orientation of the catheter tip portion tohelp guide the tip of the second wire guide into the opposite (or side)branch of the duct or vessel. Orientation within the work site can befacilitated with a rotatable handle to direct the tip. Furthermore, ithas been demonstrated that certain shorter wire guides, such as theillustrative 185 cm biliary wire guide of the present invention, aresufficiently torqueable such that an operator can simply rotate the wirewith his or her fingers to achieve similar results in most instances.

In another aspect of the invention, primary access devices furtherinclude an elongate engagement member configured to releasably engagewith the wire guide within or about the coupling region (e.g., thedistal passageway of the tubular member). Embodiments include using aflexible wire stop (e.g., a nylon stylet) configured to wedge the wireguide within the passageway when in the fully advanced position, and athread-like member (e.g., suture) that ensnares the wire guide andprovides tension to maintain it in a longitudinally secure positionrelative to the tubular member. When an elongate engagement member isnot used during introduction, such as when secondary access devices arebeing introduced over the already indwelling wire guide, a stiffeningstylet may be optionally maintained in the passageway of the tubularmember to add rigidity to the device during introduction and/or foradvantageously traversing scives in the tubular member, such as the sideaccess port, to prevent kinking thereabout.

In still another aspect of the invention, the system of devices adaptedfor remote uncoupling or ultra-short wire techniques includes a deliverycatheter for plastic tubular drainage stents and a technique fordeployment that allows for placing multiple stents side by side withinthe bile duct using a single cannulation procedure. By placing the sideaccess port on the inner carrying member (over which the stent ismounted) at a point distal to the stent, the wire guide can be uncoupledwithin the duct and the stent deployed without having to withdraw theentire system, including the wire, in the process. The junction betweenthe inner carrying member and wire guide can be advantageously used to‘catch’ the stent when the inner member is pulled back, thus allowingthe entire delivery system, including the stent, to be pulled backwithin the duct. This feature, which is not present in other stentdelivery systems, is especially important to address situations when thestent is advanced too far into the duct and needs to be repositioned.After the stent is in the correct position for deployment, the innercarrying member is advanced and/or the wire guide withdrawn to uncouplethe two, allowing the inner carrying member to be withdrawn through thestent and from the duct while the wire guide remains behind for a secondstent delivery catheter (and additional stents) to be advanced into theduct and placed along side the first stent. Pigtail stents and othersthat include shaped distal portions for anchoring can be temporarilystraightened during delivery by the wire guide which traverses thecoupling region.

In still another aspect of the invention, the wire guide can be placedthrough the mouth by dragging or carrying the wire down using aendoscope and guide wire carrying mechanism that either resides in thechannel of the scope and engages the wire guide about the scope tip, orattaches to (or co-extends with) the scope and engages the wire guidealongside. The treatment site, such as the gastroesophageal (GE)junction, is visualized and the distance to the mouth is measured usingscale indicia located on the proximal portion of the scope. The wireguide, still coupled to the wire guide carrying mechanism, is thenadvanced a known distance (e.g., 10 cm) past the treatment site and intothe stomach where uncoupling takes place following treatment. The wireguide includes a reference marking (e.g., at 10 cm) which lies at aknown reference point relevant to treatment, such as the GE junction.The proximal portion of the wire guide preferably includes scaleindicia, such as different colored bands or interverals (e.g., 5 cm)having different numbers or types of markings that reference aparticular distance (typically using non-numerical indicia) to thereference mark at the GE junction. With the wire guide in position, theoperator advances a primary access device, such as a dilator, PDTballoon, achalasia balloon etc., using corresponding indicia on theproximal portion thereof that align with that of the wire guide to guideplacement of the device to the desired treatment site, such as the GEjunction. If a secondary access device is required, such as a largerdilator, the first device is advanced into the stomach over the wire anduncoupled so that the wire becomes available for the next device to befed thereover. Carrying the wire outside of the scope to a treatmentsite, which may also include the jejunum or other portions of thegastrointestinal tract, advantageously provides a means for placingdevices larger than scope accessory channel, while still retaining thebenefit of endoscopic navigation within the patient.

BRIEF DESCRIPTION OF THE DRAWING

Embodiments of the present invention will now be described by way ofexample with reference to the accompanying drawings, in which:

FIG. 1 depicts a perspective view of a prior art sphincterotome adaptedfor short-wire exchange;

FIG. 2 depicts a cross-sectional view taken along line 2-2 of FIG. 1;

FIG. 3 depicts the device of FIG. 1 being used with an endoscope;

FIG. 4 depicts a side view of an illustrative catheter configured foruse in the illustrative system and method;

FIG. 5 depicts a cross-sectional view of the distal portion of theembodiment of FIG. 4 and illustrative wire guide coupled thereto;

FIG. 6 depicts a side view of an embodiment of the present inventionwherein the coupling region comprises an external channel;

FIG. 7 depicts a side view of a wire guide in which the proximal portionis oriented at an angle relative to the distal and intermediateportions;

FIG. 8 depicts a side view of an embodiment of proximal system ofindicia located on the first elongate medical device and wire guide;

FIGS. 9 a-f depict the steps of an example of the present method inwhich multiple catheter devices are exchanged over a guide wire withinthe common bile duct;

FIG. 10 depicts a side view of an embodiment of the present inventionwherein the first elongate medical device comprises a balloon catheter;

FIG. 11 depicts a view in situ of a sphincterotome of the presentinvention being used to introduce a second wire guide into a branch of apassageway;

FIG. 12 depicts a perspective view of an illustrative wire guide holdingdevice of the present system and method;

FIG. 13 depicts a side view of a wire guide having a coupling mechanismfor attaching a second wire guide to the proximal end thereof;

FIG. 14 depicts a side view of a retrieval basket of the presentinvention that includes a coupling ring to engage the wire guide;

FIGS. 15-16 depict cross-sectional views of sphincterotome catheterscomprising a splittable wire guide passageway;

FIG. 17 depicts a side view of a biliary stent and delivery catheter ofthe present invention;

FIG. 18 depicts a side view of an embodiment of the present inventioncomprising a splittable region in the tubular member;

FIG. 19 depicts a side view of a dilation balloon of the presentinvention;

FIG. 20 depicts a side view of an extraction balloon of the presentinvention;

FIG. 21 depicts a side view of a biopsy device of the present invention;

FIG. 22 depicts a side view of a self-expanding prosthesis deliveryapparatus of the present invention;

FIG. 23 depicts a partially sectioned side view of a first embodiment ofan elongate engagement member (distal portion) comprising a wire stopmember;

FIG. 24 depicts a side view of the proximal portion of the embodiment ofFIG. 23;

FIG. 25 depicts a partially sectioned side view of a second embodimentof the elongate engagement member comprising a thread-like member;

FIGS. 26 a-b depict a third system of indicia located on theintermediate, viewable portion of the coupled devices of the presentinvention;

FIG. 27 depicts a cross-sectional view of a stent and pusher apparatusof the present invention;

FIG. 28 depicts a cross-sectional view of radioactive seed deliveryapparatus of the present invention;

FIGS. 29 a-e depict a method of delivering multiple stents within thecommon bile duct using the system embodied in FIG. 17.

FIG. 30 depicts a partially sectioned view of a wire-guided wire of thepresent invention;

FIGS. 31-32 depict partially sectioned views of embodiment of thepresent invention in which the coupling region is located on a separatemember;

FIG. 33 depicts a side view of an embodiment of the present inventionhave two distal side access ports;

FIG. 34 depicts perspective view of an embodiment of the presentinvention in which the wire guide hooks into the side access port;

FIGS. 35 a-b depicts side views of a hooked wire guide before and afteruncoupling;

FIG. 36 depicts a side view of an embodiment of the present inventioncomprising a pair of slotted coaxial members.

FIG. 37 depicts a cross-sectional view of the embodiment of FIG. 36taken along line 37-37;

FIG. 38 depicts a partially sectioned view of an introducer member ofthe present invention;

FIG. 39 depicts a partially sectioned view of a delivery catheter of thepresent invention;

FIG. 40 depicts a side view of and embodiment of the present inventioncomprising a tactile alignment indication system;

FIG. 41 depicts a side view of a pigtail drainage catheter of thepresent invention in its deployed configuration;

FIG. 42 depicts a partially sectioned view of the embodiment of FIG. 41coupled to a wire guide;

FIG. 43 depicts a side view of an alternate embodiment of a drainagecatheter having anchoring flaps;

FIG. 44 depicts a side view of a dilator catheter of the presentinvention;

FIG. 45 depicts a side view of a wire guide of the present inventionadapted for being carried by an endoscope to a work site;

FIG. 46 depicts a side view of device attached to an endoscope which forcarrying the wire guide of FIG. 45;

FIG. 47 depicts an end view of the embodiment of FIG. 46;

FIG. 48 depicts a side view of a wire guide carrying mechanism of thepresent invention;

FIG. 49 depicts a cross-sectional view of the distal portion ofembodiment of FIG. 48 engaging a loop tip wire guide;

FIG. 50 depicts a side view of the loop tip wire guide of FIG. 49;

FIG. 51 depicts a side view of a photodynamic therapy balloon of thepresent invention;

FIG. 52 depicts a plan view of a the devices of FIG. 50 and 51 beingintroduced through a bite block/wire guide holder of the presentinvention;

FIG. 53 depicts a side view of an achalasia balloon of the presentballoon;

FIG. 54 depicts a partially sectioned view of a naso-enteric tube of thepresent invention including a stiffening stylet;

FIGS. 55 a-f depicts steps of esophageal dilation using the presentmethod;

FIG. 56 depicts a side view of an dilator having a reduced diameterportion proximal to the side access port;

FIG. 57 depicts a wire guide of the present invention that includes alubricious intermediate portion;

FIG. 58 depicts a partially sectioned side view of an embodiment of anelongate engagement member (distal portion) comprising an alternativewire stop member;

FIGS. 59 a-c depict cross-sectional views of alternative embodiments ofthe wire stop member of FIG. 58 taken along line 59-59;

FIG. 60 depicts a side view of the proximal portion of the embodiment ofFIG. 58;

FIGS. 61 a-b depict partially sectioned side views of an embodiment ofan elongate engagement member (distal portion) comprising anotheralternative wire stop member; and

FIG. 62 depicts a partially sectioned side view of an embodiment of anelongate engagement member (distal portion) comprising anotheralternative wire stop member.

DETAILED DESCRIPTION

An illustrative system and method for introducing a series of medicaldevices over a wire guide into a patient by remotely uncoupling thefirst device from the wire guide inside of the patient without utilizinga long wire or standard short wire exchange procedure is embodied inFIGS. 4-57. A first exemplary embodiment of the system is depicted inFIGS. 4-5, which comprises a first elongate medical device 10, such asthe illustrative tubular member 77 or catheter that includes featuressimilar to the GLO-TIP II® E.R.C.P. Catheter (Wilson-Cook Medical,Inc.), the catheter further including a coupling region 14 having afirst, distal end 75 (oriented toward the distal end of the device), asecond, proximal end 76, and an interconnecting passageway 31 sized andconfigured to receive a standard-diameter exchange wire guide 11 (e.g.,METRO® Wire Guide; Wilson-Cook Medical, Inc.) or other guiding devicesuitable for coupling to the first elongate medical device 10. Thecoupling region 14, generally located about the distal portion 13 of thetubular member 77 (first elongate medical device 10), may be coincidentwith the distal portion of the main passageway 27 (as depicted) orseparate therefrom. The distal portions 13,60 of the fist elongatemedical device 10 and the wire guide 11, to which the former is coupledvia the coupling region 14, are generally defined as the portion of eachthat are disposed within the work site during the medical operation andthe subsequent uncoupling of the two devices. For purposes of thisdisclosure, the work site is defined as the lumen, duct, organ, vessel,other bodily passage/cavity, or the pathway leading thereto, in whichwire guide access is maintained to perform a particular medicalprocedure/operation or series of procedures. For example, in a procedureinvolving the biliary system, the work site is considered the commonbile duct, including the pancreatic duct and the ducts extending intothe lobes of the liver.

The coupling region is configured to permit the first elongate medicaldevice 10 to be co-introduced over the wire guide (either sequentiallyor together) into the work site in a coupled state (e.g., with the wireguide 11 traversing the passageway 27 of the first device 10) such thatthe proximal portion 59 of the wire guide exits the passageway and isexternal to the tubular member 77 as the wire guide 11 and tubularmember exit the patient or scope. Like traditional forms of short wireor rapid exchange, this gives the physician more control over the wireat that point. In the illustrative coupling region 14 of FIGS. 4-5, thefirst end 75 thereof comprises a distal opening 19 in the tubular member77, and the second end 76 comprises a side access port 15 or scivetraversing the side wall of the tubular member 77 and locatedapproximately 6 cm from the distal end 12 of the tubular member. Theillustrative coupling region 14 is located within the distal portion 13of the first elongate medical device 10 with the coupling regionpassageway 31 comprising the distal portion of the main wire guidepassageway 27. The range of lengths of the coupling region 14 or thedistance of the side access port 15 (or second end 76) from the distalend 12 of the elongate member 10 can vary according to the device andapplication as long as the disconnect point is sufficiently close to thedistal end of the device to allow for remote uncoupling within the worksite. It has been determined that 6 cm is an advantageous couplingregion length for many biliary devices of the present invention in thatit provides a sufficient length to prevent accidental uncoupling, whilestill allowing for the anatomical constraints of the duct such that, inmost instances, there remains sufficient room for the relative movementrequired for uncoupling.

For biliary applications, the length of coupling region could range fromless than 1 cm (e.g., a ring) to at least 15 cm. A more preferred rangefor most devices would be approximately 3-10 cm with the most preferredrange being approximately 5-7 cm. For devices intended for thepancreatic duct, the ideal distance of the side access port 15 to thedistal end 12 would be 2-5 cm, given the shorter available distance inwhich to work. In devices intended for use in body cavities where spaceis even tighter, the side access port 15 may need to be placed closelyadjacent to or at the tip 12 of the device in order for an exchange tobe successfully accomplished. On the other hand, procedures in whichloss of wire guide access in not particularly of concern, such as incertain vascular procedures and when working in long passageways, suchas in the intestinal tract, there may be more options as to where theside access port 15 and coupling region 14 can be located.

The illustrative side access port 15 comprises a semicircular opening(in a cross-sectional view or ovoid shape from a top view) thattypically comprises approximately ¼ to ⅓ of the width of the catheter;however, any opening size or shape that permits passage of the wireguide therethrough is possible. It may be advantageous to reinforce theside access port 15 area with one or more wires, sheaths, bands,braiding, or other means which traverse, are bonded to, embedded within,or otherwise reinforce the tubular member at least within the area aboutthe wire guide exit port (side access port) to prevent kinking at thatlocation. The wire guide 11 extends proximally from the distal opening19 of the first device 10 and exits the passageway 31 and couplingregion 14 proximally through the side access port 15, thereby giving thephysician access to the proximal end of the wire such that it can bemanipulated and locked or otherwise secured during the procedure, if sodesired. As noted above, a relatively short distance of the couplingregion 14 advantageously allows the coupled devices to be moved relativeto each another by a sufficient distance to disengage or uncouple onefrom the other by advancing the catheter 10 toward the distal tip 25 ofthe stationary wire guide 11, withdrawing the wire guide until it pullsthrough the catheter and exits the side access port 15/coupling region14, or a combination of forward catheter movement and wire guidewithdrawal, all preferably in such a manner that the wire guide stillremains within the work site (e.g., the duct) to facilitate access bysubsequent devices over the indwelling wire.

Insomuch that no external exchange is required with the presentinvention, it is only necessary to size the length of the wire guide 11to account for the furthest point the distal portion 60 is to beadvanced into the work site (e.g., for uncoupling to take place), theintermediate portion 97 extending from work site, to the outside of thepatient or scope, and the proximal portion 59 (FIG. 7) extendingtherefrom for a length sufficient to be manipulated by the operator,such as to lock the wire guide in place. In the illustrative biliaryembodiment, the wire guide 11 is 185 cm in length so as to provide aminimal, but adequate extension of the wire from the scope accessorychannel; however, other procedures might necessitate a shorter or longerlength. Although the length of the wire guide 11 need only be ofsufficient length to manipulate or lock or secure in place, ifnecessary, the proximal portion 59 preferably should be sized toaccommodate a traditional short wire exchange procedure, using theappropriately configured devices, if one is required (such as whenremote uncoupling may not be possible or desirable for some reason). Thewire guide 11 is preferably sized to slidably and releasably residewithin the coupling region with minimal friction, although a mechanismis contemplated as part of the present invention in which the catheter(or coextending ancillary device) releasably engages and locks with thewire at a particular point therealong. The coupling region 14 of FIG. 5comprises the distal portion of the passageway 27 (passageway 31), withthe proximal portion 28 of the passageway providing a continuation ofthe lumen that extends proximally from the point of the side access port15. Alternatively, the proximal passageway 28 can be at least partiallyblocked or restricted (with a moveable flap or a permanent obstruction,such a plastic or metal insert) just proximal to the side access port 15to serve as a guide or ramp that helps the wire guide being loaded fromthe distal opening 19 to be able to more readily exit through the sideaccess port, rather than continuing on into the proximal passageway. Theblocking means (not shown) may also advantageously restrict fluid orother materials from passing through the passageway retrogradedirection. In a related embodiment, the wire guide passageway 27 extendsproximally only to the side access port 15, terminating at that point.

While the illustrative coupling region 14 of FIGS. 4-5 represent apreferred embodiment for applications in which having the wire guide 11extending from the distal opening 19 of the tubular member 77 isparticularly advantageous, such as for primary access devices used tocannulate a tight stricture, such as the ampullary orifice, it should benoted that any structural adaptation that allows for temporary couplingof the wire guide to a device being introduced therewith or thereovercan comprise an embodiment of the coupling region 14 for purposes ofremote uncoupling. For example, FIG. 6 depicts a alternative embodimentof the present invention in which the coupling region 14 comprises anexternal coupling element or channel 30, rather than a portion of thetubular member passageway 27. The illustrative external channel 30,which includes a passageway 31 extending therethrough, can either beintegrally formed with the catheter body, or can be bonded or otherwiseattached to the outside thereof Additionally, the external channel 30can comprise a short piece of sheath encircling the tubular member 77, aplastic or metal ring, or any structure that can form a passageway 31capable of forming a coupling region 14 with the wire guide.

FIG. 30 depicts an embodiment of an external channel 30 for a device nothaving an internal passageway. The elongate medical device 10 comprisesa wire-guided wire 111 in which the coupling region 14 comprises a outerchannel 30 comprising a outer sleeve 112 of shrink wrap material bondedto the wire 111 and a inner sleeve 113 of a radiopaque material bondedto the first sleeve 112 as indicator 17,18 of the first and second ends75,76 of the coupling region 14. Either a standard wire guide (such as a0.021″ METRO™ wire guide) is fed through the coupling region and the twowires are advanced through an already indwelling tubular member to thework site, or the wire-guide wire 111 is fed over the proximal end of anindwelling standard wire guide (which could also be coupled to a tubularmember) and advanced to the work site, where it is uncoupled therein.

FIG. 14 depicts another alternative embodiment in which the couplingregion 14 comprises a coupling ring 63, which in the illustrativeembodiment is attached to the distal tip 74 of a retrieval apparatus 64,such as the illustrative wire retrieval basket 64 for capturing biliarystones (a modification of the WEB™ Extraction Basket, Wilson-CookMedical, Inc.). The illustrative ring 63 is advantageously made to pivotso that it can better accommodate the wire guide 11 which passestherethrough to engage with the first device 10. Coupling rings 63,while not providing as secure of an engagement of the internalpassageway, represents an option for certain types of devices lacking asuitable passageway within the shaft portion of the elongate medicaldevice 10 (made of coiled wire in this particular embodiment). The ring63 requires the least amount of relative movement between devices foruncoupling, which can be advantageous in short work sites or when facedwith other anatomical constraints.

FIGS. 31-36 depict a series of alternative coupling region 14embodiments. FIG. 31 depicts a tubular member 77 in which the couplingregion 14 is located on a separate element, which in the illustrativeembodiment, comprises an elongate engagement member 89 comprising ashaft portion 164 slidably disposed in a second passageway 115 andextends from the distal end 12 of the tubular member 77 and engages thewire guide 11 via a cannula portion 115 that includes first and secondopenings 75,76 through which the wire guide 11 is fed. By locating theelongate engagement member 89 within a second passageway 115, the firstpassageway 27 remains available for infusing materials or passing asecond wire guide therethrough. The embodiment of FIG. 32 also includesa separate elongate engagement member 89 in a second passageway 115 withthe elongate engagement member 89 further comprising the coupling region14. In this illustrative embodiment, the elongate engagement member 89extends from the side access port 15 and includes a distal ring or loop45 which ensnares the wire guide and couples the devices together.Optionally, the loop 45 can be made collapsible to pull through thepassageway 115 after uncoupling.

FIG. 33 depicts a tubular member in which the first end 75 of thecoupling region 14 terminates proximal to the distal end 12 of themember, and the second end 76 comprises a side access port 15 locatedabout the distal portion 13 of the tubular member. The wire guide 11 isfed into the coupling region 14 such that the distal end 25 of wireguide 11 is directed at an angle from the tip 12 as it exits the mostdistal side access port (first end 75). This configuration allows thephysician to be able to rotate the tubular member 77 to advantageouslydirect the tip 25 of the wire guide 11 in an intended direction, such asinto a particular branch 48,49 of a bifurcated duct or vessel. Thedistal end 12 of the tubular member 77 can be closed, or it couldinclude an opening about the tip that could represent a second,alternative first end 75 of the coupling region so that if preferred,the wire guide 11 can also be coupled in the manner similar to FIG. 5.

FIGS. 34-35 b depict embodiments of the present invention in which thewire guide 11 is adapted to hook into the coupling region 14 in acoupled configuration. In the embodiment of FIG. 34, the wire guide 11includes a hooked distal portion 116, such as the illustrative‘shepherd's crook’ in which the distal end 25 and adjacent distalportion 60 engage the coupling region 14 of the tubular member 77 viathe side access port 15, residing within the passageway 27 by an amountsufficient to accomplish a secure engagement. Preferably, the wire guide11 is sized such that there is a adequate frictional engagement with thepassageway 27 in which it resides to help prevent accidentaldislodgement. In a related embodiment shown in FIGS. 35 a-b, the distalhook portion 116 of the wire guide 11 is configured to be inserted intothe distal opening 19 of the tubular member 77, which includes aradiopaque marker band 17 closely proximate thereto. The illustrativedistal hook portion 116 comprises nitinol or another superelasticmaterial which allows it to be heat set in a helical configuration 117that once disengaged from the passageway 31 of the coupling region 14,the hook 116 assumes its predetermined shape and wraps back over itselfto create a closed loop end 118. This configuration better permits asecond device to be fed back over the wire guide 11 without the hookedportion 116 interfering with its passage thereover. Optionally, thetubular member 77 can include an open longitudinal channel or recessextending proximally from the side access port 15 or distal opening 19in which the coupled wire guide 11 can at least partially reside whilethe devices are being advanced together into the work site.

Another embodiment of a method of coupling a tubular member 77 to a wireguide 11 is shown in FIGS. 36-37 in which the tubular member comprises apair of coaxial members 100,119 that each include a slotted opening orchannel 120,121 extending the length of the coupling region 14 (distalend 12 to side access port 15) such that when aligned with one another,the wire guide 11 can laterally disengage from the open passageway 31,which is otherwise enclosed by one of the inner 119 and outer 100 sheathmembers when they are not aligned. Preferably, the proximal portions ofthe inner and outer members 100,119 (not shown) include proximal makingsor structure that allows the physician to determine when rotationalalignment has occurred for uncoupling. Alternatively, the slots 120,121can include radiopaque stripes extending therealong that whensuperimposed on one another or are otherwise aligned in some manner,indicate radiographically that alignment has occurred such the wireguide can disengage from the passageway 31.

The above coupling region 14 embodiments are merely exemplary of themany options from which a skilled person might select to couple acatheter and wire guide together for introducing them to a work site,the choice being influenced by the nature of the procedure and thedevices being used. Other selected examples include, but are not limitedto releasable or breakable sutures or wires extending along or throughthe catheter to capture the wire, compatible, engageable surfacestructure or elements located on both devices, temporary or dissolvablebonds or adhesives, magnets, or other means of temporarily coupling twomedical devices.

Preferably, devices configured for remote uncoupling include analignment indicator system that allows the clinician to determine thecurrent state of alignment or engagement between a given device and thewire guide or guiding member to which it is temporarily coupled for aparticular procedure. In procedures that utilize fluoroscopic guidanceof devices within the work site, strategically located radiopaqueindicia conveniently provide a means for determining relative alignmentand confirmation that uncoupling has occurred. The invention does notrequire that a particular imageable maker be of a particular type. Forexample, ultrasonically reflective markers can be used in place ofradiopaque bands or other markers. Further, the number and arrangementof the markers is not critical. The alignment indicator system of thepresent invention may comprise any suitable system in which the firstelongate device 10 and wire guide 11 include a predetermined orprecalibrated method or means of providing guidance to the physician viaexternal imaging, direct observation (external or endoscopic), tactilesensation, or monitoring of an audible or visual alarm sensor (e.g.,activating an indicator light located about the proximal end of theapparatus) to indicate that uncoupling of the two device has occurredwithin the work site.

Referring now to FIGS. 4 and 5, the procedure for uncoupling the firstdevice 10 and wire guide 11 within the work site is greatly facilitatedby the addition of a first system of indicia 16 located about the distalportions 13,60 of the first device 10 and the wire guide 11,respectively, that comprise a series of radiopaque markers which providevisual guidance under fluroscopic imaging to the physician or operatoras to when the first device is coupled with the wire guide and when thewire guide has passed through and out of the coupling region 14. Sincerelatively few exchange procedures can be performed under direct visualobservation, the distal indicia 16 typically include a series ofexternally imageable bands, marking, or other indicia comprising aradiopaque (high density) material, such as, iridium, platinum,tungsten, gold, barium, tantalum, etc. The indicia are overlaid upon,bonded to, or incorporated into the device at the desired locations,typically a location useful for relative alignment with other radiopaqueindicia or structure. The illustrative first (or distal) system ofindicia 16 comprises a series of radiopaque markings on both the firstelongate medical device 10 (tubular member 77) and the wire guide 11,including an optional distal imageable marking 17 located about thedistal end 12 of the tubular member (or first end 75 of the couplingregion), a proximal imageable marking 18 located proximate and distal tothe side access port 15, and a distal imageable portion 26 or markerlocated about the distal end 25 or distal portion 60 of the wire guide11. The illustrative distal marking 17 of FIG. 4 comprises radiopaqueink having sufficient radiopacity to contrast with the catheter shaft,which in the illustrative embodiment, is also made radiopaque by theaddition of barium sulfate or other suitable material into the basepolymer. The proximal imageable marking 18 comprises an iridium orplatinum band that is glued or otherwise affixed to the catheter surfaceclosely adjacent the distal end of the scive comprising the side accessport 15. This band comprises sufficient radiopacity such that itcontrasts well with the tubular member to which it is attached, whichalso may include radiopaque material or pigment. In FIG. 5, the distalradiopaque marker 17 of the tubular member 77 comprises a band similarto band 18 at the proximal end 76 of the coupling region (side accessport 15). The illustrative distal radiopaque wire guide portion 26 (FIG.5) comprises a coilspring comprising platinum, or another radiopaquematerial such as tungsten or gold. Use of radiopaque filler material orink is also contemplated as a means for creating a radiopaque wire guidetip portion 26. Placement of a radiopaque marker 18 about the second end76 of the coupling region 14 advantageously provides a target point atwhich the physician knows if the radiopaque tip 26 of the wire guide haspassed proximal thereto and disengagement has occurred. Although in theillustrative embodiments, the marker 18 is typically located proximaland closely adjacent to the side access port, it may also be placed inany suitable position that is useful for alignment with the wire guide,such as proximal of the port or in alignment therewith, such as depictedin FIG. 6. Alternatively, the marker 18 can comprise a radiopaque stripeor sleeve that extends the length of the coupling region, rather thanbeing limited to the area adjacent the side access port. One suchexample is depicted in FIG. 31 in which the illustrative metal couplingcannula 114 comprises a highly radiopaque material such as platinum oriridium. In the embodiments of FIGS. 14 and 32, the coupling region 14comprises a coupling ring 63 which preferably includes enhancedradiopacity to assist the physician in determining when the radiopaquedistal portion 26 of the wire guide has passed through and disengagedfrom the ring.

A second system or type of indicia 21 is depicted in FIGS. 4 and 8, andis located on a proximal portion 36 of the first device 10/tubularmember 77 that is external to the patient when the distal portion 13 ofthe device is residing within the work site. During normal operation,the proximal indicia 21 are directly visible by the clinician during theprocedure as a primary or secondary means of determining alignment. Inthe biliary embodiment of FIG. 8, the proximal indicia 21 compriseindicia 35 located about the tubular member 77 and include a series ofprinted bands that are preferably of a color or pattern contrasting withthat of the tubular member 77, and which extend from 160 cm (the firstor distal end 62) to the 166 cm mark (second or proximal end 61), asmeasured from the distal tip of the catheter. The first end 62 (160 cm)represents the point at which alignment with a corresponding proximalalignment mark 37 located on the wire guide, comprises the point ofalignment 81 which indicates that uncoupling is imminent with furtherrelative repositioning between the two devices 10,11. Repositioning theproximal alignment mark 37 of the wire guide toward the second end mark61 results in the two devices reaching the point of detachment 82 atwhich uncoupling takes place, the colored bands serving as warning thatthe uncoupling is imminent with further repositioning. In the embodimentof FIG. 4, the proximal indicia 21 comprise a continuous band ofcontrasting coloration extending from 160 to 166 cm. As noted, thelocation of the proximal indicia is not particularly critical, but it ispreferably configured such that it remains visible to the operatorduring a typical procedure. The band 35 can include a gradation ofcolors, (e.g., yellow to orange to red) to indicate the relativeproximity to the point of detachment 82. In the illustrative embodiment,the 166 cm mark at the proximal end of the indicia band 35 liesproximate the distal end of an optional proximal side access port 20,which comprises an entry point for a second wire guide into thepassageway 27, the technique therefor being discussed below. Fornon-biliary applications, such as for vascular, pulmonary, or urologicalprocedures, etc., any proximal indicia 21 most likely would be locatedat a different lengths from the distal tip of the catheter, oneappropriately correlated with the distance required to access the worksite. The length of the first device indicia 35 (6 cm) preferablycorresponds with the length of the coupling region 14 (shown in FIG. 5).

As noted above, the 160-166 cm area of indicia 35 of the proximal indicasystem 21 advantageously provides a location on the tubular member 77that will most always be external to the patient and endoscope accessorychannel such that it can be viewed by the clinician during theprocedure. In the illustrative embodiment, the second alignment point 37of the wire guide is indicated by a color change between the distalportion 60, which includes helical striping characteristic of the METRO®Wire Guide (Wilson-Cook Medical, Inc.), and the proximal portion 59,which comprises solid coloration, such as a section of shrink wrap orcoating of a different color and/or pattern that visually contrasts withthe distal portion 60 and/or intermediate portion 97 such that thedistal 160 cm of the illustrative wire guide are distinct from anddifferent in appearance from the proximal 25 cm. Alternatively, acontrasting color or ink or suitable material can be applied to theouter surface of the wire guide 11, or a single band can be affixedabout the junction 37 between the distal 60 and proximal 59 portions atan appropriate location to establish the point of detachment 82 whichoccurs by alignment with point 61 of the first device 10. The secondalignment point 37 is located on the wire guide 11 such that when it isaligned with the distal end 62 of the proximal indicia 21, the distalend 25 of the wire guide is aligned with the distal end 12 of the firstdevice 10/tubular member 77. Alternatively, the wire guide could includea single, narrow marking at the second alignment point 37, or multiplemarkings, e.g., corresponding to both the proximal and distal ends 61,62of the proximal indicia 21. The proximal indicia 21 of the wire guide 11and catheter 10 comprise any suitable means of providing a visualindicator, such as shrink wrap, ink, bands, surface etching or othertreatment, etc.

A third type of alignment 83 is depicted in FIGS. 26 a and 26 b in whichthe first and second endoscopic alignment indicators 84,85 are locatedabout the intermediate portions of the first elongate medical device 10(or second catheter, etc.) and wire guide 11, respectively, in alocation such that when the distal portions thereof are advanced withinthe work site 41, the first and second indicators 84,85 are typicallydisposed within the viewable area 86 between the Papilla of Vater 40 andthe distal end 87 of the accessory channel. This allows the operator tomonitor the relative alignment of both to determine when uncoupling hasoccurred within the duct 41 (biliary system). In the illustrativeexample, the distal ends of the wire guide and first catheter member(not shown) have both traversed the Papilla of Vater 40, and entered thebile duct 41. An optional marking 29 at 10 cm (depicted in FIG. 4 as apair of printed bands) can be included on the first elongate medicaldevice 10, which is viewable as the device is being introduced into theduct 41. The 10 cm mark 29 can be used for guidance to indicate that thefirst device 10 has been advanced a minimally ‘safe’ or sufficientdistance into the duct, this occurring once the 10 cm mark 29 hasdisappeared from view, as shown in FIGS. 26 a-b. At this point, theendoscopic alignment indicators 84,85 are normally located within theviewable area 86. In FIG. 26 a, the first endoscopic alignment indicator84 of the catheter is located proximal to the corresponding secondendoscopic (wire guide) indicator 85, indicating that the wire guide 11is fully coupled to the first device 10 (i.e., completely traversing thecoupling region). In the illustrative method, the operator utilizes theintermediate system of indicia 83 to determine when uncoupling of thedevices 10,11 has occurred by advancing the first device 10 relative tothe stationary wire guide 11 (which typically is locked down or securedagainst movement to maintain access within the duct), as shown in FIG.26 b. As the two indicators 84,85 become aligned, the distal end of thewire guide exits the proximal end of the coupling region or side accessport (not shown) and uncoupling or disengagement takes place. As afurther endoscopic indicator to prevent loss of wire guide access out ofthe duct during uncoupling, the distal portion 60 (e.g., the distal 6cm) of the wire guide 11 can comprise a different coloration, such asblack, so that it contrasts with the intermediate portion 97 (depictedin FIG. 7). When the physician sees the black portion of the wire guideemerging from the papilla, the wire should be advanced back into theduct to minimize the risk of having to recannulate. If uncoupling hasyet to take place and the distal black portion 60 of the wire guide isvisible endoscopically, then both the wire guide 11 and tubular member77 should be advanced further into the duct so that uncoupling cansafely take place without risking loss of access.

An example of a non-visual system of alignment is depicted in FIG. 40 inwhich the wire guide 11 includes a surface irregularity 160, such as theillustrative bead, that is configured such that when it passes throughthe second end 75 of the coupling region 14, e.g., through the sideaccess port 15, the operator feels or senses the contact between them,thus indicating that uncoupling is imminent with further repositioning.The illustrative side access port 15 is configured to include a flexibleskirt 158 that includes an opening 159 sized to allow free passage ofthe wire guide 11, but causing temporary resistance as the bead 160passes therethrough. Furthermore, the skirt portion 158 canadvantageously act as a seal to help prevent leakage of bile, blood, andair into the passageway of the tubular member. Other possibly surfaceirregularities include ridges, bumps, teeth, indentations, or aroughened portion that along with an appropriately configured sideaccess port 15 or coupling region 14, provide tactile feedback to theoperator and thus, guidance to the state of alignment and engagementbetween the two devices.

Endoscopic devices used to perform medical procedures within the biliarysystem are typically divided into what could be called ‘primary accessdevices’, which typically comprise the initial device used in theprocedure to cannulate the Spincter of Oddi and access the duct, and‘secondary access devices’ for which the primary access device isexchanged to perform one or more operations within the work site.Examples of primary access devices of the present invention includesphincterotomes for ablating the sphincter to enlarge the opening to theduct (depicted in FIGS. 10-11), needles knives (not shown), which arealso used to cut the sphincter, and ERCP catheters (FIGS. 4-5), whichare adapted to infuse contrast media into the duct for radiographicimaging. Sphincterotomes and needles knives may also be configured toperform dual or multiple functions or operations, such as the infusionof contrast media and other agents. Some sphinctertomes include balloonused for sweeping the duct to remove calculi or stones lodged therein.Other devices, such as extraction balloons, may be used as both primaryand secondary access devices. In pancreatobiliary procedures, primaryaccess devices are exchanged for secondary access devices that aretypically configured to perform a therapeutic function, such as toextract or crush stones, sample tissue, deliver radiation or lighttherapy, dilate or stent strictures (e.g., tumors), or place stents fordrainage. If the secondary access device represents the last device usedin a particular procedure, it need not be adapted for remote uncoupling,although it preferably would include at least a distal coupling regionso the device can be advanced over a short wire without requiring anextension being added thereto. Generally speaking, virtually anysecondary access device (extraction, dilation, or phototherapy balloons,dilator, forceps, brush, stent delivery catheter, brachytherapycatheter, lithotriptor, basket, snare, etc.) that is normally introducedinto the biliary system over a wire can be adapted for remote uncouplingby the addition of a suitable coupling region within the distal portionof the device and preferably, but not necessarily, at least one of thethree aforementioned systems of indicia to provide positive confirmationof uncoupling and relative alignment of the devices.

An exemplary method of using a primary access device (first elongatemedical device 10), a wire guide 11, and a secondary access device(third elongated medical device 44) of the present invention to accessand perform a medical operation in a work site 41 is depicted in FIGS. 9a-f. The initial steps of the illustrative method include a standardendoscopic technique for accessing the biliary duct 41 to performdiagnostic and therapeutic procedures. FIG. 9 a shows a duodenoscope 38that has been introduced via the oral cavity into the duodenum 39 tovisualize the Papilla of Vater 40 and Sphincter of Oddi, which lie atthe opening to the common bile duct 41 and the pancreatic duct. In theexemplary method, a dilator catheter 88 and wire guide 11 are advancedfrom the accessory channel of the scope 38 to cannulate a stricture 42within the work site 41 (duct). It is general physician preference thatdetermines whether the wire guide 11 is advanced past the tip of theprimary access device 10 to assist in cannulation or whether the distalend 25 of the wire guide is within the passageway 27 during this part ofthe procedure. As depicted in FIG. 9 b, the dilator catheter 10 (orother secondary access device) is advanced over the wire guide 11 withthe proximal portion of the wire guide exiting the side access port 15and extending through the channel alongside the catheter so that bothseparately exit the accessory channel of the scope as depicted in FIG.12. For applications where the size of the scope channel is restrictedor other applications where there is limited room to accommodate bothdevices side by side, the catheter can be modified to allow for the wireguide to lie alongside without increasing the overall diameter. This canbe done by forming an open channel (preferably one that would notcapture the wire) or creating a flattened longitudinal portion along thelength of the catheter (not shown).

Still referring to FIG. 12, the proximal portion 59 of the wire guide 11is typically, but not necessarily, secured in place once the distal end25 thereof has been advanced to the desired position within the worksite 41. The illustrative wire guide holder 50 represents an improvementover prior art devices in that it is configured to be partially insertedinto or over the opening 52 of the access port 51 to the accessorychannel and provide a seal, rather than being secured elsewhere on thescope. The holder 50 further includes an optional integrated sealingelement 65 having one or more types of seals, including duckbill,membrane with slit (e.g., polystyrene, silicone, or another compliantpolymer material), foam seal with small central aperture (e.g., silicon,polyurethane, etc.), or other designs having the ability to seal aroundthe catheter and wire guide to prevent any proximally migrating fluidfrom exiting the channel. The wire guide 11 is locked in place byinterweaving it through a first series of spaces 53 (or channels,grooves, slots, etc) between spaced elements located along one side of alocking portion 66 of the device, such as the illustrative curved‘spine’, using an alternating under/over manner as depicted. Theillustrative holder includes three slots 53 or spaces on the first sideand a second series of three slots 54 or spaces on the opposite side ofthe locking portion 66 to accommodate a second wire, if one is necessaryfor the procedure.

Unlike other wire guide exchange procedures where the proximal end ofthe wire guide is well out of the way of the physician, the short wirestypically used in the illustrative remote uncoupling or ultra-short wiretechniques usually result in the proximal end of the wire guide beingwithin the physician's working area so that access thereto is readilyavailable for introducing secondary devices to the work site. While theillustrative holder is configured to direct the proximal end portion ofthe wire guide downward and out of the way of the physician, theproximal end, when unsecured to feed another device over the wire, maydeflect back up into the working area around the access port of thescope and can interfere with the physician during the procedure. To helpalleviate this problem, FIG. 7 depicts a wire guide 11 in which theproximal end portion 59 thereof is oriented at an angle 79 with respectto the distal and intermediate portions of the wire so that the proximalend 58/proximal end portion 59 is typically oriented down and away fromthe operator (when rotated as such) and thus, out of the working areasurrounding the access port of the endoscope while still allowing thephysician to access the proximal end for the advancing the next device.In the illustrative embodiment, which comprises an 185 cm nitinol corewire guide 11 in which approximately 40-45 cm thereof typically isextending proximally out of the scope as the third elongate medicaldevice is being advanced thereover, the bend 80 or point of deflectionis preferably located about 20-30 cm from the proximal end, although theuseful range may be anywhere from 0-50 cm. The useful angle 79 ofdeflection depends on physician preference, the configuration of thescope and wire guide holder, and other factors, but is generally about30-120° for endoscopic procedures with a more preferred range of 45-90°for the illustrative embodiment. To create the bend 80 in a nitinol wireguide 11, the material can either be heat set or mechanicallyoverstressed (‘cold working’) to achieve the desired angle 79 ofdeflection and radius of the bend 80 (e.g., small, relatively acute bendor a large, more gradual or rounded bend).

Referring now to FIG. 9 c, once the wire guide has been advanced to thedesired location within the work site, the catheter is advanced or drawnback over the wire guide to position it for performing the intendedoperation. In the illustrative method, this involves the injection ofcontrast media 43 into the duct 41 to visualize the obstruction, whichcomprises a stricture 42 in this particular instance. Another commonalternative approach to diagnosing potential obstructions in the ductswould be to initially introduce a sphincterotome 32 (FIG. 10) to injectcontrast media 43. If an obstruction is found, such as a stone, thesphincter might be ablated and a second device, such as a basket orballoon, is introduced over the original wire guide to extract the stonefrom the duct. A variety of other treatment possibilities exist andthus, it should be understood that the nature and sequence of thedevices used is not critical to the present invention.

Once the initial operation has been concluded, the first elongate device10 can be removed from the duct 41. As depicted in FIG. 9 d, theoperator can conduct a device IDE by repositioning the distal ends ofthe ERCP catheter and wire guide 12,25 toward one another by advancingthe catheter (as depicted), or preform a wire guide IDE by unlocking thewire guide 11 from the wire guide holder and drawing it back until thedistal end 25 disengages from the catheter. Alternatively, the cliniciancan disengage or uncouple the device and wire guide 10,11 by moving bothdevices simultaneously until the wire guide exits the coupling region,typically keeping them within the work site 41 while uncoupling takesplace. As discussed earlier, imageable indicia 18,26 on the distalportion 13 of the catheter 10 and the distal end 25 of the wire guide11, respectively, are utilized to confirm under fluoroscopy thatdisengagement or uncoupling has occurred, as shown in FIG. 9 e. Theproximal indicia 21, depicted in FIGS. 4 and 8, and/or intermediateindicia 83 (FIGS. 26 a-b) may also be utilized to provide confirmationthat uncoupling has taken place within the work site. This optional stepis shown in FIG. 12 in which the wire guide 11 is in the locked position161 within the illustrative wire guide holder 50, which is attachedabout the opening 52 of the biopsy port of the scope (over the rim ofthe port and/or inserted therein), is subsequently disengaged and placedin the unlocked position 162 adjacent the primary access device 10 sothat the proximal indicia 21 of the two devices 10,11 can be aligned. Aslong as the proximal mark 37 of the wire guide 11 remains distal of thealignment mark 81 of the primary access device 10, the operator knowsthat distal tip of the wire guide is still protruding from the distalend of the catheter within the duct (not shown). When the wire guide 11is withdrawn (or primary device 10 advanced) such that the two marks37,81 are in alignment, the operator knows the distal ends 12,25 of thetwo devices 10,11 are generally aligned within the duct. As the operatorcontinues to draw back the wire guide 11 or advance the catheter 10, thealignment mark 37 becomes aligned with the disengagement mark 82, whichin the illustrative embodiment is indicative that the distal end of thewire guide has pulled completely out of the passageway or coupling areasuch that the two devices are uncoupled within the duct.

Once uncoupling has taken place, either device 10,11 becomes availableas a conduit for introduction of a third elongate medical device to thework site. In the illustrative method depicted, the third elongatedevice 44 comprises a dilation catheter 88 (FIG. 9 f) that is introducedover the wire guide 11 by feeding the back end 58 of the wire guide 11(not shown) into the distal opening 19 of the dilation catheter 88 andout of the side access port 15, then advancing the dilation catheter 88into the accessory channel of the scope, over the wire, and on into theduct 41. Typically, the operator would choose to remove the first device10, if no longer needed, before introducing the third device 44. This isdone simply by having the operator pull the catheter out of the duct andscope channel in one continuous motion while maintaining the wire guidein position (e.g., such as locked within the wire guide holder 50 ofFIG. 12). Once the first device 10 is removed and the third device 44 isadvanced to the work site, the second medical operation (e.g., dilationof the stricture) can be performed. If another operation is required, athird catheter-type device (fourth elongate medical device) can beadvanced over the original wire guide 11 and so on.

As noted above, the present system of introducing and exchanging devicesover a wire guide is adaptable such that a long wire guide can beintroduced through a suitably configured medical device that has beenintroduced using the ultra-short wire method. In other instances, it maybe desirable to convert an indwelling ultra-short wire to a longer wirefor use with a non-compatible device. FIG. 13 depicts a wire guideextender 56 for use with the present system to accommodate an externalexchange with either a conventional medical device (‘long wire’) lackingthe side access port for intraductal exchange, or conventional rapidexchange devices in which a somewhat longer external exchange (e.g., 30cm) is required. In the illustrative system, the wire guide 11 includesa coupling mechanism 55, such as a thread or wire loop, on the proximalend 58 that is configured to engage with a second coupler 57, such asthe illustrative hook, located on the distal end of the wire guideextender 56. This effectively extends the length of the wire guide sothat a conventional over-the-wire exchange can take place in the eventthat a particular device not designed for ultra-short wire exchange isto be used with the present system. One skilled in the art would readilyappreciate the various types of coupling mechanisms that would besuitable to accomplish the extension of the wire guide for purposes ofan exchange. They include locking or screw mechanisms, sheaths, bands,etc. that permit the two portions 11,56 to be joined temporarily orpermanently. Another option is to use an adhesive strip or similardevice to attach the wire guide 11 and extender 56 to one another.

The illustrative system of devices that allow for uncoupling within thework site and elimination of the external exchange over the wire canalso be adapted for the introduction of second wire guide via anindwelling, uncoupled catheter into the work site, after placement ofthe first wire guide. FIG. 10 depicts catheter 10 that includes aproximal access port 20 (third opening) located within the proximalportion of the catheter at a point that typically lies outside of thepatient during a procedure (approximately 166 cm in the illustrativebiliary device example). The proximal side access port 20 may include anoptional sleeve cover that slides over and closes the access port whenit is not in use.

To introduce a second wire 46, the illustrative sphincterotome 32, oncedisconnected from the first wire guide 11, is not removed from thepatient as in the method depicted in FIGS. 9 a-f. Rather, the tip of thesecond wire guide 46 (third elongate medical device 44) is fed into thewire guide passageway 27 via the proximal opening 20 and advancedthrough the scope and into the duct 41. In the example of FIG. 11, thefirst wire guide 11 resides in a first branch 48 of a bifurcation, suchas where the common bile duct 41 branches into the two lobes of theliver. The sphincterotome 32 carrying the second wire guide can berotated and deflected by the physician, by using the handle to pull backthe cutting wire, to advantageously direct the advancing second wireguide into the opposite branch 49 such that each branch is nowcannulated by the wire guide 46. A sphincterotome 32 having a handlethat provides axial rotation of the catheter body is preferable fororienting the distal cutting portion 33 into or toward the opposite ductfor placement of the wire. Once the second wire 46 is in its desirelocation, it can be locked in place (e.g., using the second series ofslots 54 of the illustrative wire holder 50 of FIG. 12). After thesphincterotome or other primary access device 10 has been removed fromthe second wire 46, both wires 11,46 are available for subsequentplacement or introduction of additional devices, such as stents torestore or improve patency of the ducts.

Removal of the original catheter device 10 from the short second wire 46requires that either an exchange must take place, such as by adding thewire guide extender 56 of FIG. 13 to perform a long-wire exchange; orthe catheter may be peeled off of the wire 46 if the portion of the wireguide lumen 27 that lies between the distal (side) and proximal sideaccess ports 15,20 is configured to allow wire to laterally exit thepassageway. This can be accomplished in a number of well-known waysincluding forming a weakness in the wall, such as making a score line,slit 67 or other pre-weakened area inside of the wall, such as thatdepicted in FIG. 15, or intermittent perforations formed partially orcompletely through the wall to weaken it longitudinally. Alternatively,the tubular member can comprise an intact catheter wall that isconfigured to fail when sufficient lateral pressure is exerted by thewire guide residing in the passageway. One method of doing this is tomake the wall 68 adjacent the wire guide lumen 27 sufficiently thin(FIG. 16) and and/or of a suitable polymer such that when lateral forceis applied against the catheter, the wire guide 46 readily splits ortears through the thin wall 68 as the catheter is being withdrawn fromthe patient. A material with a suitable molecular structure to encouragesplitting, such as an isotropically oriented polymer, may be used or thepolymer may be treated in some manner to encourage splittability. Theentire catheter wall can be configured to facilitate splittability, orthe splittable portion may be limited to one specific region along thecircumference thereof, such as including a longitudinal coextrusion of asecond, lower durometer extending to the outside of the wire guidelumen. Rather than (or in addition to) configuring the wall to increasesplittability, a tab or other element can be attached or integrated intothe catheter to facilitate a manual split to remove the wire guide. Asharp tool or similar device represents yet another alternative methodof accessing the guide wire lumen to separate the catheter from thewire. Another option is to extend the groove completely through the wallto form a narrow, open channel or a sealable or locking seam such thatthe two edges either are biased against one another or interlock byvirtue of their complimentary structure. The seam is designed to splitopen or unlock when the lateral force supplied by pulling the wire guidethereagainst is sufficient to force it open.

Returning now to the IDE method depicted in FIGS. 9 a-f, it has beennoted that the friction encountered when introducing a primary accessdevice and a coupled wire guide through the accessory channel of anendoscope can, in some instances, cause premature disengagement of thetwo device before they reach the work site. FIGS. 23-25 depict differentembodiments of an elongate engagement member 89 which is configured toreleasably secure the wire guide 11 to the tubular member 77, such thatunwanted disengagement or relative movement does not occur as thedevices are being introduced or manipulated within the patient. In FIG.23, the elongate engagement member comprises a wire stop member 90preferably made of a flexible polymeric material with adequate columnstrength, such as nylon, which is similar in configuration to a standardpusher member. Other suitable materials may include PEEK, PTFE,stainless steel, nitinol, polyethylene, or polypropylene materials ofvarious densities. Preferably, the wire stop member 90 comprises adiameter (e.g., 0.035″) that substantially fills the inner diameter ofthe passageway 27 of the tubular member 77 such that when fully advancedto a point distal to the side access port 15 where the wire guide 11enters the coupling region 14 (passageway 31), the wire stop member 90contacts and wedges the wire guide 11 against the inner wall of thepassageway, thereby substantially preventing longitudinal movement ofthe wire guide 11 relative to the tubular member 77. FIG. 23 illustratesthe wire stop member 90 disposed within a single-lumen tubular member77; however, it may be used in multi-lumen device (e.g., asphincterotome) as well. FIG. 24 depicts the proximal hub 92 (a maleluer fitting) of the wire stop member 90 in a retracted position 94 inwhich the wire stop member 90 is not sufficiently advanced to engage andlock or wedge the wire guide 11 within the passageway 27 at the regionor point 91 just distal to the side access port 15. To do so, theproximal hub 92 is advanced to a forward position 95 in which the hub 92contacts and engages the proximal (female) fitting 93 located at theproximal access port 23 of the primary access device 10. Once theoperator wishes to reposition the two devices 10, 11 relative to oneanother, the proximal (male) hub 92 is disengaged from the femaleproximal hub 93 and drawn back until the wire guide 11 is released.Preferably, but not necessarily, the wire stop member 90 is removablefrom the passageway 27 such that agents, additional wire guides, etc.,may be introduced therethrough. An elongate engagement member 89 istypically not used with a secondary access device insomuch that the wireis already indwelling within the work site and the need to secure thewire guide to the device is unnecessary.

A second embodiment of an elongate engagement member 89, depicted inFIG. 25, comprises a thread-like snare member 96 made of suture, wire,cable, or other strand of material which loops around, ensnares, orotherwise releasably engages the wire guide 11 within the passageway 27.Wire guide 11 may include a groove or depression (not shown) in thesurface thereof into which snare member 96 can be positioned so as toprevent the wire guide 11 from sliding along snare member 96 The snaremember 96 can be attached to an actuating portion of the handle to givethe operator sufficient control over its operation. When the operatorwishes to disengage the wire guide 11 from the tubular member 77,tension is released on the snare member 96, or it can be cut or one endreleased so that it can be withdrawn from the passageway 27.Alternatively, the snare member 96 can be disposed on the outside of thetubular member 77 to releasably engage and secure the wire guide 11.

Additional embodiments of an elongate engagement member 89 are depictedin FIGS. 58-62. In FIG. 58, the elongate engagement member 89 comprisesa wire stop member 190 having a softened distal tip. The softened tipallows the end of the wire stop member 190 to deform (compress) so as toincreases the area of surface contact with both the inner wall (ofpassageway 27) of the tubular member 77 and the exterior surface of thewire guide 11. This increased surface area increase the frictionalforces, and consequently the stopping or “braking” force between thecomponents. In addition, the softened tip also reduces the possibilityof damage to the wire guide 11 or tubular member 77 that may be causedby wire stop member 190 as it is jammed against or in between thesecomponents. Wire stop member 190 further comprises one or moreradiopaque markers 196 positioned near the distal tip thereof. Theseradiopaque markers 191 can assist a user, utilizing fluoroscopy, indetermining whether the wire stop member 190 is engaged with the wireguide 11. FIG. 58 illustrates the wire stop member 190 disposed within amulti-lumen tubular member 77 of the type that may be used in amulti-lumen device such as a sphincterotome.

FIG. 59 a is a cross-sectional view of the elongate member 89 of FIG. 58taken along line 59-59. As depicted therein, wire stop member 190 issubstantially circular in cross-section and has a diameter that issomewhat smaller than the interior diameter of passageway 27 of tubularmember 77. Although wire stop member 190 is illustrated as having asolid cross-section, it should be understood that a non-solidcross-section may be utilized in alternative embodiments. For example,wire stop member 190 could comprise a lumen extending through a portionor the entire length thereof. The presence of a lumen may enhance thecompressibility of the wire stop member 190 so as to increase frictionalcontact with both the inner wall (of passageway 27) of the tubularmember 77 and the exterior surface of the wire guide 11. A lumen mayalso be utilized for delivering contrast media or other agents throughthe wire stop member 190. With respect to the latter, wire stop member190 may comprise an injectable stylet.

FIG. 59 b is an alternative cross-sectional view of elongate member 89of FIG. 58 taken along line 59-59. As depicted therein, wire stop member290 is non-circular in cross-section. In particular, wire stop member290 comprises a plurality of outwardly projecting ribs 291 that areconfigured to engage and deform about wire guide 11 and more readilyfill the gap between wire guide 11 and the inner wall (of passageway 27)of tubular member 77 in the engagement region 191 (see FIG. 58). Theribs 291 also help to keep the wire stop member 290 centered within thepassageway 27 of tubular member 77, as well as reducing the likelihoodthat the wire stop member 290 will inadvertently pass out through sideaccess port 15 (see FIG. 58). The channels 292 which are formed betweeneach adjacent pair of ribs 291 provide a passageway for contrast mediaor other agents passing through passageway 27.

FIG. 59 c is another alternative cross-sectional view of elongate member89 of FIG. 58 taken along line 59-59. As depicted therein, wire stopmember 390 is non-circular in cross-section. In particular, wire stopmember 390 includes a pair of outwardly projecting flanges or wings 391that are configured to slidably engage with a similarly shapeddepressions in and along the length of the inner wall (of passageway 27)of tubular member 77. In other words, wire stop member 390 has anon-circular cross-sectional shape that matches the non-circularcross-sectional shape of the passageway 27 of tubular member 77. Ofcourse, it should be appreciated that the cross-sectional area of wirestop member 390 is somewhat smaller than that of passageway 27 so as toallow the former to freely slide with the latter. It should also beappreciated that the cross-sectional shape of passageway 27 is such thatit will still accommodate an elongate member, such as wire guide 11,having a circular cross-section.

The cross-sectional shape, and more specifically wings 391, prevents thewire stop member 390 from twisting within passageway 27. Moreimportantly, wings 391 prevent wire stop member 390 from inadvertentlypassing out through the side access port 15 of tubular member 77 (seeFIG. 58). As illustrated in the drawing, the wings 391 are preferablydisposed along the sides of the passageway 27 generally opposite of theside access port 15 so as to not interfere with the movement of the wireguide 11 therethough. Other non-circular cross-sectional shapes can alsobe employed to accomplish the functions and benefits described above.For example, wire stop member 390 and passageway 27 could have a squareor triangular cross-section. The cross-section of the passageway willpreferably, although not necessarily, still be capable of accommodatinga wire guide 11 therethrough.

In FIGS. 61 a-b, the elongate engagement member 89 comprises a wire stopmember 490 that extends through a second passageway 427 of the tubularmember 77. The cross-sectional area or diameter of the second passageway427 decreases or narrows in the region 429 of the tubular member 77 justdistally of the side access port 15 to a cross-sectional area ordiameter that is less than that of the wire stop member 490. Inaddition, the portion of the wall 428 that separates the secondpassageway 427 from the first passageway 27 in this region 429 isrelatively flexible and/or thin.

FIG. 61 a illustrates the distal end of the wire stop member 490 in thedisengaged position. In this position, the distal end of the wire stopmember 490 is located proximally of the region 429. The cross-sectionalarea or diameter of the portion of the second passageway 427 occupied bythe distal end of the wire stop member 490 is greater than thecross-sectional area or diameter of the wire stop member 490. FIG. 61 billustrates the distal end of the wire stop member 490 in the engagedposition. In this position, the distal end of the wire stop member 490is located within the region 429. The cross-sectional area or diameterof the portion of the second passageway 427 occupied by the distal endof the wire stop member 490 is less than the cross-sectional area ordiameter of the wire stop member 490. As a result, the distal end of thewire stop member 490 forces the portion of the wall 428 (that separatesthe second passageway 427 from the first passageway 27) to move into thefirst passageway 27 so as to engage and pinch the wire guide 11 withinthe first passageway 27.

In FIG. 62, the elongate engagement member 89 comprises a wire stopmember 590 that similarly extends through a second passageway 527 of thetubular member 77. Wire stop member 590 comprises an inflatable member591 that is in fluid communication with an inflation device, such as asyringe (not shown), connected to the proximal end of the wire stopmember 590. When the inflatable member 591 is inflated, it pushesagainst the portion of the wall 528 that separates the second passageway427 from the first passageway 27. As in the embodiment illustrated inFIG. 61 b, movement of the portion of the wall 528 into the firstpassageway 27 causes the wall 528 to engage and pinch the wire guide 11within the first passageway 27. It should be appreciated that othertypes of expandable devices could also be employed as an alternative toinflatable member 591. For example, an expandable wire basket could beaffixed to the distal end portion of wire stop member 590. A separatecontrol wire or mechanical linkage device could also be employed tocompress the passageway 27 about the wire guide 11 so as to prevent thewire guide 11 from longitudinally moving relative to the primaryelongate medical device 10.

FIG. 60 depicts the proximal hub 192 (a male luer fitting) of the wirestop member 190 in a retracted position 194 in which the wire stopmember 190 is not sufficiently advanced to engage and lock or wedge thewire guide 11 within the passageway 27 at the region or point 191 justdistal to the side access port 15. To do so, the proximal hub 192 isadvanced to a forward position 195 in which the hub 192 contacts andengages the proximal (female) fitting 193 located at the proximal end ofextension tube 198, which is affixed or otherwise attached to accessport 23 of the primary access device 10. Once the operator wishes toreposition the two devices 10, 11 relative to one another, the proximal(male) hub 192 is disengaged from the female proximal hub 193 and drawnback until the wire guide 11 is released. Preferably, but notnecessarily, the wire stop member 190 is removable from the passageway27 such that agents, additional wire guides, etc., may be introducedtherethrough. However, and as noted above, wire stop member 190 maycomprise a non-circular cross-section (see, e.g., FIG. 59 b), a lumentherethrough, or other configuration that would permit contrast media orother agents to pass through passageway 27 while wire stop member 190 isdisposed therein.

Wire stop member 190 further comprises a stiffened proximal shaftsection 197 configured to prevent kinking or excessive bending as thewire stop member 190 is pushed into engagement with the wire guide 11.The proximal shaft section 197 may be susceptible to kinking orexcessive bending because it is disposed outside of lumen 201 (ofelongate primary device 10), and is therefore unsupported until wirestop member 190 has been fully inserted into the passageway 27 of theprimary elongate device 10. In the particular embodiment shown,stiffened proximal shaft section 197 comprises a PEEK material having adiameter or cross-section that is greater than the diameter orcross-section of the more distal shaft section 200 of wire stop member191. Alternatively, stiffened proximal shaft section 197 comprises anover-tube that is disposed over the shaft of the wire stop member 190.To accommodate the larger diameter or cross-section of stiffenedproximal shaft section 197, extension tube 198 comprises a lumen 199having an enlarged internal diameter or cross-section that is greaterthan the diameter or cross-section of lumen 201 of passageway 27. Inother words, extension tube 198 is configured to accommodate theincreased diameter or cross-section of stiffened proximal shaft section197. In the alternative, stiffened proximal shaft section 197 couldcomprise a relatively stiff material such as a metal wire, therebyallowing the proximal shaft section 197 to have the same diameter orcross-section as that of distal shaft section 200 by utilizing. Thisalternative construction would permit the proximal shaft section 197 topass into lumen 201 of passageway 27, thereby eliminating the need forextension tube 198. It should be appreciated that extension tube 198 canbe configured for attachment to various types of catheter devices 10having a variety of proximal access port 23 configurations. In otherwords, extension tube 198 can be configured for attachment topre-existing catheter devices 10, including those manufactured bydifferent entities, so as to permit these pre-existing catheter devices10 to be modified for use with wire stop member 190.

The distal shaft section 200 of wire stop member 190 can comprise eitheruniform or non-uniform physical properties along the length thereof. Inthe embodiment discussed above, distal shaft section 200 is manufacturedfrom a single type of material and has a constant diameter orcross-section, thereby giving the distal shaft section 200 a uniformstiffness or flexibility. In the alternative, the distal shaft section200 may be manufactured so as to have different physical propertiesalong different portions thereof. For example, the distal shaft section200 may be tapered or stepped (i.e., decreasing diameter orcross-section) towards the distal end so as to increase the flexibilitythereof, which may be beneficial when performing certain medicalprocedures. Likewise, increasing the stiffness of the distal shaftsection 200 towards its proximal end can allow the wire stop member 190to be used to enhance the stiffness of the primary elongate device 10.The distal shaft section 200 may also utilize different materials, ormaterials that have been otherwise altered to have different properties,for different portions or sections of the shaft. The use of differentmaterials can be used in combination with, or separately from,dimensional changes in the distal shaft section 200. The distal shaftsection 200, or portions thereof, may also be treated with surfacecoatings, such as hydrophilic coatings, to decrease the frictionalresistance of moving the wire stop member 190 through passageway 27 ofthe primary elongate device 10.

The elongate engagement member 89 embodiments of FIGS. 31 and 32 alsoinclude the coupling region 14 of the device 10 that may be configuredto be partially retractable back into the secondary passageway 115. Thisaction creates a frictional engagement with the wire guide such that theelongate engagement member 89 further acts as a stop to prevent the wireguide 11 from sliding freely within the coupling region 14.

It should be understood that the above-described embodiments of theelongate engagement member 89, and more particularly wire stop members90, 96, 190, 290, 390, can be utilized to secure a wire guide 11 to anytype of elongate medical device 10 having an intermediate side accessport 15 in communication with an internal passageway 27. In other words,elongate engagement member 89 can be utilized with rapid exchange, shortwire, ultra short wire, and convertible devices. Furthermore, thedepicted embodiments represent but a few of the possible types ofdevices adapted for securing the first elongate medical device 10 andwire guide 11 so that they can be co-introduced through a channelwithout disengaging therein.

The present invention and method includes using devices in procedureswhere once the primary access device is used within the work site, asecondary access device is introduced over the guiding device (wireguide) which has been uncoupled from the primary device within the worksite. In the biliary tree, a number of possible devices may beintroduced to perform a variety of medical procedures, a few selectedexamples of which are depicted in FIGS. 9F,14,17,19-22, 27-28, 39,41-44, 51, and 53. The exemplary devices are certainly notrepresentative of all secondary access devices appropriate for use inthe bilary tree, nor is their use particularly limited to being asecondary device used following a primary device. The illustrativedevices depict some of the general types of medical devices usedendoscopically in the biliary tree, as well as other non-biliary andnon-endoscopic procedures performed elsewhere in the body.

FIG. 17 depicts a system for delivering a biliary or pancreatic drainagestent 69 mounted on a delivery catheter 110 (elongate medical device 10)of the present invention. The illustrative COTTON-LEUNG® Biliary Stent(Wilson-Cook, Medical Inc.) is mounted on an OASIS® One Action StentDelivery System (Wilson-Cook Medical, Inc.), modified for IDE, whichextends through the internal lumen 72 of the stent 69, which is slidablymounted thereover (when used with a pusher member 101 (see FIGS. 29a-c). It should be noted that the illustrative stent delivery catheter110 is configured to accept different kinds of tubular drainage stentsin addition to the type shown. The coupling portion 14 of the deliverycatheter 110 comprises the passageway 27 between the distal opening 19and the side access port 15, which is located 1.5-2.0 cm from the distaltip. A proximal marking 18, such as the illustrative iridium band, islocated at about 1 cm, just distal to the access port 15. The wire guide11 exits the side access port 15 at a point distal to the distal end 71of the stent 69 to advantageously provide a means for withdrawing thestent 69 along with the delivery catheter 110, which greatly assists inthe ability to reposition the stent within the duct. When the catheter10 and wire guide 11 are withdrawn together relative to the stent (whichis held stationary by the pusher member), the distal edge 71 of thestent 69, which is slidably positioned over the catheter, lodges in atriangular wedge point 70 formed by the junction of the deliverycatheter and the wire exiting therefrom. Thus, the stent 69 is pulledbackward along with the delivery catheter, providing the clinician witha simple and reliable means to pull the stent partially out of the ductso that the proximal anchor flaps 73 can extend outside of the duct, ifso desired. Once positioned at the desired location, the wire guide 11and delivery catheter 110 are uncoupled and the latter is withdrawn fromthe lumen 72 of the stent 69. In delivery systems in which the wireguide 11 extends through the lumen 72 of the stent 69, pulling back onthe delivery catheter 110 would not allow the clinician to pull thestent back with it without an additional mechanism to releasably couplethe stent to the delivery catheter. It should be noted that this methodcan be readily adapted for other stent designs as well, particularlyother non-expandable tubular stents and those having pusher members.

The illustrative stent delivery system of FIG. 17 is particularlywell-adapted for placement of multiple stents as depicted in the methodof FIGS. 29 a-e, insomuch that remote uncoupling of the wire guide 11and apparatus 10 can be performed within the duct, unlike previousbiliary stent delivery systems, thereby eliminating the need forrecannulating the papilla for each stent placed. As depicted in FIG. 29a, the inner delivery member 110, which is coupled to the wire guide 11,is advanced out of the endoscope 38, through the ampullary orifice 40and into the duct 41. The wire guide 11 does not extend through thelumen of the stent 69 and pusher member, which is not yet shown. In FIG.29 b, the pusher member 101 urges the stent over the inner member 110until the distal end 71 thereof reaches the junction 70 formed where thewire guide 11 exits the side access port (alternatively, the innermember 110 and stent 69 can be pulled back while the pusher member 101contacts the stent and causes it to advance further up over the innermember 110). As noted above, the junction 70 can be used to contact thedistal end 71 of the stent and pull back or reposition the stent 69,such as when it had been advanced too far into the duct for idealdeployment. Once the stent 69 is in the proper position for deployment,as depicted in FIG. 29 c, the inner member 110 is advanced further intothe duct 41 so that there is sufficient room for the uncouplingprocedure to take place. The wire guide 11 is unlocked from the wireguide holder 50 (see FIG. 12) and pulled back until it exits the sideaccess port 15, as depicted in FIG. 29 d. The inner member 110 is thenwithdrawn through the stent 69, along with the pusher member 101, andremoved from the channel of the endoscope. The wire guide 11 is thenre-advanced further into the duct to serve as a conduit for the nextstent delivery system, shown in FIG. 29 e, such that a second stent 109can be deployed alongside the first in the manner shown in FIGS. 29 a-d.Subsequent deployments of additional stents can be also be made usingthe same technique over the original wire guide.

Other stent or prosthesis delivery systems configured for use with thepresent invention are depicted in FIGS. 22, 27, and 39. FIG. 22 depictsa delivery system 99 for a self-expanding prosthesis 98, which couldinclude a self-expanding stent, such as the Wilson-Cook ZILVER™ BiliarySelf-Expanding Stent or any nitinol, stainless steel, or otherself-expanding stent; artificial valve (e.g., venous, heart, pulmonary,etc.) prosthesis, vessel occluder, filter, embolic protection device,shunt, stent graft, etc. The illustrative apparatus comprises an innermember (elongate medical device 10) on which the prosthesis 98 ismounted and an outer member 100 or sheath which constrains theself-expanding prosthesis 98 until deployment. The side access port 15is located about 3 cm from the distal tip 12 of the inner member 10 withthe coupling region 14 being completely distal to the prosthesis 98.

An alternative system for deploying a self-expanding prosthesis isdepicted in FIG. 39 which includes a series of corresponding slots inthe inner and outer members 10,100 to allow for relative repositioningduring deployment (the sheath 100 typically being drawn back while theinner member 10 of the delivery system is maintained in position). Thispermits the coupling region 14 to extend through the prosthesis 98 andallow the wire guide 11 to exit the side access port 15 proximal to theprosthesis 98, which would allow the wire guide to reside inside and bedeployed inside prosthesis 98, and as a result, less chance of losingaccess to the work site. This may be especially advantageous indeployment of stents, other prostheses, and other ancillary devices,such as dilation balloons, within the vascular system in thatrecannulation through the deployed stent may be problematic, possiblyleading to complications such as dislodgement or catching on thedeployed stent, dislodgement of plaque, etc. With regard to placement ofartificial venous and other types of artificial valves, maintaining wireguide access through the valve may be particularly advantageous in thatrecannulation through the leaflets or valve structure to deployadditional valves or introduce a seating balloon to fully expand thevalve support frame against the walls of the vessel may proveparticularly difficult, possibly leading to damage of delicate leafstructure and compromise of valve function.

FIG. 27 depicts an endoscopic biliary stent 69 and pusher apparatus 101(typically 5.0-7.0 FR) which is configured for ultra-short wire andrapid exchange use. It primarily differs from the embodiment of FIG. 17in that it lacks the inner member. Both the stent 69 and pusher member101 (the elongate medical device 10 in this particular embodiment) areintroduced through an outer introducer member 100, where the distal end12 of the pusher apparatus 101, which includes the coupling region 14about its distal portion 13, urges the stent forward for deploymentwithin the duct. The side access port 15 is located about 6 cm from thedistal end 12 of the pusher member 101 (elongate medical device 10) suchthat the wire guide traverses the passageway of the stent 69.

FIGS. 41-42 depict another embodiment in which the stent 69 comprises apigtail drainage stent 126, such as the illustrative naso-biliarydrainage stent, that includes a curved anchor portion 127 in thedeployed configuration 128 (FIG. 41) that is configured to assume astraightened configuration 129 when placed over a wire guide 11 forintroduction into the bile duct, as shown in FIG. 42. Preferably, butnot necessarily, the drainage holes 130 disposed along the distalportion of the stent 126 are sized such that the wire guide 11 cannotreadily exit therethrough (e.g., 0.025″), whereas the side access port15 is sized to easily accommodate the exiting wire guide (e.g., 0.035″or larger). In the illustrative naso-biliary embodiment, there are fivedrainage holes distributed about 6 mm apart along the distal portion 13distal to the side access port 15 and marker band 18. In this particularembodiment, there is a series of optional drainage holes 130 proximal tothe side access port 15 as well. The spacing of the drainage holes canvary according to the diameter of the curl, generally ranging from 5 mmto 1 cm or more. As the wire guide 11 is repositioned relative to thestent 126 to perform an intraductal exchange, the anchoring portion 127recoils into its intended shape when the wire guide is no longer insidethe coupling region passageway 31. The illustrative embodiment couldalso be adapted for use as a naso-pancreatic drainage stent, ureteral orurethral stent, or other stent having one or more curved or pigtailedend portions and various configurations of drainage holes. Theillustrative embodiment of FIG. 41 further includes an intermediatecurved portion that allows the stent to better conform with the anatomyof the pancreatobiliary tract and duodenum into which it is placed.

Another embodiment of naso-biliary and naso-pancreatic drains isdepicted in FIG. 43 that is similar to the embodiment of FIGS. 41-42,except that it includes a pair of distal anchoring flaps 180 and lacksthe pigtail anchoring portion. Furthermore, the side access port ispreferably located closer to the distal end 12 of the device (e.g.,about 2 cm vs. about 6 cm for the pigtail embodiment). Typicallynaso-biliary drains are 5-10 FR in diameter while the naso-pancreaticdrains are 5-7 FR. Both the pigtail and non-pigtail drain embodimentsmay advantageously include a stiffening stylet (depicted in FIG. 43)that extends to about the side access port 15 and provides pushability,as well as straightening out a loop or bend, if present, locatedproximal to the side access port. Such a bend may allow the device toconform to the anatomy of the patient, such as to better traverse thecontours of the duodenum. An example of the bend or curved portion 172is shown in FIG. 41.

FIGS. 19-20 depict balloon 47 embodiments of the present invention thatare adapted for short wire use. FIG. 19 comprises a dilation balloon 47(a modified QUANTUM™ Biliary Balloon, Wilson-Cook Medical, Inc.), whichis made of a non-compliant material (e.g., PET) such that balloon member102 can be inflated to a predetermined diameter to dilate a stricturewithin the duct. FIG. 20 comprises an extraction balloon 47, such as amodified TRI-EX™ Triple Lumen Extraction Balloon (Wilson-Cook Medical,Inc.), which comprises a non-compliant material (latex, silicone, etc.)which is adapted for sweeping the duct of material, such as stones,sludge, etc. Both embodiments include a side access port 15 about 6 cmfrom the distal end 12 of the catheter 10 such that the coupling region14 extends through the balloon member 102 and exits proximal thereto.The embodiment of FIG. 20 further illustrates a removable stiffeningstylet 103 that is maintained within the passageway 27 of the cathetermember 10 to provide rigidity, especially across the side access port 15(and optional proximal side access port, not shown) such that kinking isless likely to occur at that point. The stylet, preferably made of metal(e.g., stainless steel) or a relatively stiff plastic or other material,would not provide any engagement function similar to the distal wirelock 90 of FIG. 23 in most applications since that would interfere withthe ability to advance the device over the wire guide.

FIG. 21 depicts a biopsy device 104 for collecting cells within thebiliary tree. The illustrative embodiment, which comprises a modifiedCytoMAX II™ Double Lumen Biliary Brush (Wilson-Cook Medical, Inc.),includes a side access port 15 about 6 cm from the distal end 12 of thetubular portion 77 of the device 10 and a brush element 105 disposedabout the distal end and extending beyond such that the coupling region14 terminates proximal of the brush element 105, the distal opening 19for the wire guide 11 being disposed about the distal end of the tubularmember 77 about the base of the brush element 105. An alternative devicefor delivering a biopsy device 104 or other device within a work site isdepicted in FIG. 38. The illustrative tubular member 77 includes astandard coupling region 14 about the distal end except that thepassageway 27 of the tubular member, rather than communicating with thepassageway 31 of the coupling region 14, terminates about a rampedexternal opening 122 that is configured to accommodate a separateelongate medical device for introduction to the work site which is notdirectly coupled to the wire guide 11. The illustrative biopsy device104 can be advanced to gather a tissue sample, then withdrawn back intothe passageway 27 and either removed from the patient with theintroducing member 77, or removed therefrom and a second medical deviceadvanced into the passageway to perform a different procedure. Inaddition to the radiopaque marker band 18 to indicate the location ofthe second end of the coupling region 14, the illustrative tubularmember includes an additional marker 123 located about the rampedopening which provides additional guidance to the operator. Theillustrative biopsy device is but one example of a device deliverable inthe manner shown in FIG. 38.

Another secondary access device is depicted in FIG. 28, which comprisesa brachytherapy or radioactive seed delivery catheter 106 which includesa passageway 27 for the wire guide 11 (and which includes the couplingregion 14) and second, closed-ended passageway 107 for receiving aradioactive element 108, such as a catheter, stylet, or individualradioactive seeds that are introduced thereinto. The brachytherapydevice 106 is introduced over the wire guide 11 to the treatment site,where it is positioned for a period of time sufficient to deliver aneffective therapeutic dose of radiation to adjacent tissue, such as atumor within the biliary tree. Typically, the side access port 15 islocated about 6 cm from the tip which is preferably made of a pliable,atraumatic polymer material. The second passageway is preferably locatedcentrally so that radiation is dispersed evenly in all directions. As aresult, the first wire guide passageway may either terminate distalthereto, about the side access port 15, or be offset therefrom, at leastbecoming so at a point proximal to the side access port 15 and couplingregion 14.

FIGS. 44-57 depict a series of non-biliary devices configured forintroduction through the patient's mouth, rather than through theaccessory channel of a duodenoscope, such as the aforementionedembodiments. Placement of the embodiments of FIGS. 44-57 typicallyinvolves using an ultra-short wire guide 11 that is advanced to thetreatment site by being coupled to the outside of an endoscope. The wireguide is then uncoupled from the scope and locked in place to serve as apathway for the introduction of other devices, such as within theesophagus or elsewhere within the gastrointestinal tract. Optionally,the wire guide 11 (FIG. 57) can include a hydrophilic or otherwiselubricious coating or surface 173 (e.g., SLIP-COAT® Biopolymer, STSBiopolymers, Inc., Henrietta N.Y.) to facilitate the advancement ofdevices thereover after the wire guide has been placed. The coating isadvantageously restricted to a portion of the wire guide 11, such as theintermediate portion 97, with the proximal portion 59 that extends outof the patient and is manipulated and locked by the operation (e.g., theproximal 10-15 cm) having a standard non-hydrophilic surface (e.g.,PTFE) to make it easier to secure the wire guide in place. The distalportion 60 (e.g., 2-6 cm) of the wire guide may also be left uncoated togive the operator a better degree of control to help avoid accidental,premature uncoupling of the wire guide from the coupling region of thedevices being advanced thereover. The lubricious intermediate portion 97of the illustrative wire guide of FIG. 57 is especially advantageouswhen used in the small or colon to allow the device to slide more easilytherewithin, while still allowing the wire to be secured at each end bythe bite block and distal loop 144, respectively.

FIG. 44 and 45 depict a dilator catheter 88 and wire guide 11 comprisinga system for dilating strictures within the esophagus. The dilator 88includes a system of scale indicia 133 located about the proximalportion of the tubular member. In the illustrative embodiment, which isabout 75 cm in length, indicia are located to indicate the 40, 50, and60 cm mark to help align the device with the indwelling wire guide 11,which includes a similar series of indicia 134, such as the illustrativebands that increase in number at each 10 cm interval to indicate thedistance from a reference point. The alignment indicia 133,134advantageously permit accurate positioning of the device at thetreatment site, such as the GE (gastroesophageal) junction, a stricture,or other site that is to be dilated, irradiated, or otherwise treated,after the treatment site has been confirmed using the endoscope used tocarry the wire guide thereto.

A method for introducing the wire guide 11 and dilator catheter 88 ofFIGS. 44 and 45 into the esophagus to perform a series of esophagealdilations using successively larger dilator catheters is depicted inFIGS. 55 a-f. The basic method can also be used for introducing otherdevices that are too large to be introduced through an accessory channelof an endoscope or where standard endoscopic placement techniques eitherare not appropriate or not possible. As shown in FIG. 55 a, the wireguide 11 is carried to the work site using an endoscope 38 and a wireguide carrying mechanism 174, which in the illustrative embodimentcomprises the endoscopic wire guide holder 140 depicted in FIG. 48,which resides within the accessory channel 165 of the scope and includesa mechanism to couple with the wire guide 11 via a distal loop 144 aboutthe distal end 25 thereof. As shown, the endoscopic wire guide holder140 comprises a catheter portion having a lateral recess 142 proximatethe distal end 12 thereof and a longitudinal slidable pin member 141,disposed within a passageway 145 in the shaft 146 of wire guide holder140, that is adapted to traverse the distal loop 144 of the wire guide.The pin member 141 is advanced to secure the loop 144 within the recess142 to carry the wire guide 11, which is at least substantially outsideof the scope accessory channel 165, down to the work site, where it isreleased by the operator by actuating the finger ring portion 148 of thehandle 147 relative to the thumb ring 149 until the loop 144 slips offthe retracting pin member 141. When the pin 141 is fully advanced into alocking channel 143 that extends distally from the lateral recess 142,the loop 144 is secured and cannot slip free. The endoscopic wire guideholder 140, which is then withdrawn from the work site along with theendoscope, can either carry the wire guide 11 while partially extendingfrom the accessory channel, or be withdrawn into the accessory channel165 (as shown) such that the distal end 25 of the wire guide is pulledthereinto.

A second embodiment of a wire guide carrying mechanism 174 is depictedin FIGS. 46-47 comprising a ring element 136 that attaches to theoutside of the endoscope 38 about the distal end thereof using afriction fit, clamping mechanism, or some other well-known means, and isconfigured to releasably secure the wire guide 11 being carried to thework site. The wire guide 11 includes a detachable element 135, such asthe illustrative distal ball, which is crimped, glued, or otherwisefastened about the end 25 of the wire guide and designed to slide off orbreak apart with the application of a sufficient amount of pull force(e.g., 3 lbs.) and be safely passed through the gastrointestinal systemor be absorbed thereby. The ball tip 135 is inserted into an open slot137 in the ring 136 and then slipped laterally beneath a lip portion 138and into a recess 139 that together, help secure the wire guide andallow it to be pulled along with the scope. With the ball 135 residingin the recess 139 formed along the distal edge of the ring, the wireguide 11 can be uncoupled from the scope 38 by pulling on the proximalportion of the wire guide while maintaining a counter force against thescope 38 to keep it in place. When the ball 135 is dislodged (FIG. 45a), the wire guide 11 can slip under the lip portion 138 (FIG. 47) andthe endoscope 38 can be withdrawn from the patient, leaving the wireguide in place.

Referring again to FIG. 55 a, the endoscope is typically positionedwithin the work site 41 just proximal to the specific site (sphincter,stricture, lesion, etc.) therein that is to be treated. In theillustrative method, the scope 38 is advanced to the GE junction 156while depth markings located about the proximal portion of the scopeexiting the patient (not shown) provide the operator with the distancefrom the mouth to the treatment site. At this point, the distal end 25of the wire guide 11 is also generally positioned at the GE junction 156since it is engaged proximate the distal end of the scope 38. Theendoscope 38 and wire guide are advanced through the esophagus 155 andpositioned at the GE junction 156, where that distance is noted. Theoperator may advance the scope 38 10 cm (or some other similar,predetermined distance), which places the distal end 25 well within thestomach 157 (about 10 cm past the GE junction 156). Or, as depicted inFIG. 55 b, the operator may advance the wire guide holding device 140,which may include proximal depth indicia as well, a similar distancebeyond the scope 38 and into the stomach 157. The wire guide 11 in theembodiments depicted in FIGS. 45 and 50 include a reference mark 175located 10 cm from the distal end 25 (or whatever distance the wireguide is to be advanced past the GE junction or other anatomicalreference point). The wire guide 11 of the illustrative embodimentdepicted in FIG. 45 includes a series of proximal indicia 134 that cancomprise varying numbers of markings at selected intervals therealong(e.g., 30,35,40,45,50, and 55 cm from the reference mark 175). Inanother embodiment depicted in FIG. 50, the wire guide includes five 5cm bands 150 of different colors that span from the 30 cm mark to the 55cm mark as measured from the reference mark 175 which is 10 cm from thetip 25. The indicia 134 may further include 1 cm reference marks 177(e.g., hash marks) within each colored band 150. Preferably, the bands150 of the embodiment of FIG. 50 comprise colors that contrast with theadjacent band. For example, cool and warm colors may be advantageouslyplaced adjacent one another to create a sequence such as yellow, green,red, blue, and then orange.

Once the wire guide 11 has been advanced 10 cm past the GE junction 156,it is uncoupled from the wire guide carrying mechanism 174 and securedin place by some means such as using the illustrative bite block 151depicted in FIG. 52 with integral wire guide securing portion 154, andwhich includes straps 153 that secure the bite block 151 around thepatient's head. In addition to functioning as a mechanism 50 forsecuring the wire guide in place, it also maintains an open working area152 through which the scope, wire guide 11, and primary or secondarydevices are passed to the work site.

In instances where a narrow stricture exists that cannot accommodate thescope without risking creating a tear in the esophagus (at least withoutbeing properly dilated beforehand), the wire guide holding device 140advantageously provides a means to safely advance through and traversethe stricture to carry the wire therebeyond and serve as a pathway foradvancing the dilators, the smallest of which may be less than the scopediameter.

Now referring to FIG. 55 c, the endoscope 38 and wire guide holdingdevice 140 are typically withdrawn from the work site 41 such that theprimary access device 10, which in the illustrative method comprises afirst dilator 167, can be advanced over the wire guide 11 to perform amedical operation, as depicted in FIG. 55 d. To advance the firstdilator 167, the wire guide 11 is temporarily unlocked from the holdingdevice so that the proximal end thereof can be threaded through thecoupling region 14 of the dilator. Alternatively, the primary device 10(e.g., dilator 167) can be coupled to the wire guide 11 prior to thewire guide being advanced to the work site 41. The illustrative dilator167 includes optional radiopaque marker bands 18,132 located at the sideaccess port 15 and distal edge of the widest portion of the devicebefore the tapered end, respectively. While it is the GE junction thatis established as the anatomical reference point to which theillustrative wire guide 11 and primary access device 10 are aligned, theregion of the esophagus having the stricture to be dilated may lieanywhere proximal to the GE junction. Reference to the GE junction ispreferred to provide a consistent known distance within the stomach foruncoupling.

The dilator 167 (FIG. 44) also preferably includes a series of proximalindicia 133 as well that are aligned with the wire guide indicia 134 sothat the operator can determine when a particular point along thedilator (e.g., distal end of the widest portion 132, distal tip 12, sideaccess port 15, etc.) has reached the GE junction, the tip of the wireguide, or some other reference point.

Once the first dilator 167 has been advanced past the esophagealstricture or the GE junction 156 as the first step of enlarging theopening thereof, the distal portion 13 is advanced fully into thestomach 157 of the patient so that uncoupling can occur, as depicted inFIG. 55 e. Typically, this is accomplished by advancing the side accessport 15 past the distal end 25 of the wire guide 11, which remainslocked in place, until the distal end 25 thereof slides free of thecoupling region 14. As with the biliary techniques depicted in FIGS. 9a-f and 29 a-e, the uncoupled primary access device 10 is then removedfrom the patient and a secondary access device (third elongate medicaldevice 44) such as second (larger) dilator 168, is introduced to thework site 41 as depicted in FIG. 55 f. Esophageal dilations typicallyinvolve passage of a series of progressively larger dilators, althoughone or more of the smaller sizes may be skipped if resistance is notfelt during the initial dilation.

An alternate embodiment of a dilator catheter 167 is shown in FIG. 56 inwhich the side access port 15 is located on a proximally facing surfaceor plane 169 formed as the distal (larger) diameter portion 170 of thedilator transitions down to the smaller, proximal portion 171. Thisadvantageously eliminates having the wire guide 11 lying alongside thewidest part of the dilator 167 during passage of both through thestricture. The illustrative stepped configuration can also be useful inother embodiments of the present invention to eliminate friction causedby a wire guide passing within a sheath or channel, such as within anendoscope.

The general method of FIGS. 55 a-f can also be adapted for placement ofother devices outside of the endoscope, such as a photodynamic therapy(PDT) balloon 47, depicted in FIG. 51, or an achalasia balloon 53,depicted in FIG. 53. Both devices depicted are commercially availablefrom Wilson-Cook Medical, Inc. and shown herein as modified for ultrashort wire delivery. Positioning of the PDT balloon 47 is performed byusing the endoscope to locate the GE junction and place the wire guide11 at a suitable, known distance therebeyond, such as 10 cm, thatdistance corresponding to the reference (or ‘zero’) mark 175 of the wireguide. In the illustrative embodiment of FIGS. 50-52, the wire guideincludes colored bands 150 that correspond to those comprising theproximal indicia 133 of the PDT balloon catheter 47 such that when thecolors are aligned (FIG. 52), the reference point 176 of the device 10,which in the case of the PDT balloon, is the distal edge of thelight-emitting portion 178 of the balloon member 102, is located at theGE junction. This places the light-emitting portion 178 at the optimallocation to treat the disease (e.g., Barrett's esophagus). It should benoted that the colored bands 150 or other indicia 133,134 of theillustrative embodiments are configured for aligning the treatmentdevice 10 with the wire guide 11 and thus, the site selected fortreatment and may or may not have other functions such as to aid in thealignment of the tips 12,25 of the device with one another or with theside access port 15 to indicate that uncoupling is imminent. Separateindicia may be used for alignment relating to coupling and uncoupling.While the colored bands 150 of the wire guide 11 are configured to referback to the reference mark 175 that corresponds (in this embodiment) tothe GE junction, the colored bands 150 of the primary access device 10are configured such that alignment with those of the wire guide placesthe device in the correct position for treating the disease. Thus, theyare not necessarily (and usually are not) of the same reference scale.

FIG. 53 depicts an embodiment in which the primary access device 10comprises an achalasia balloon. With the treatment of achalasiadiffering in that the balloon is placed across the GE junction ratherthan proximal thereto, the reference point 176 that corresponds to theproximal reference indicia (not shown) and permits the device to bealigned with the GE junction, is located at the center of the balloonmember 102 rather than the distal edge as in the PDT balloon.

The technique of dragging the wire guide outside of the scope to thework site, uncoupling it, and advancing a device thereover, is alsoapplicable to a number a larger diameter catheters (FIG. 54), such asfeeding tubes (e.g., nasojejunal, nasoenteric, etc.) which are advancedvia the mouth into the stomach or small intestines for placement. Thesecatheters may advantageously include a stiffening stylet 103 in thepassageway 27 to prevent the scope from dragging the catheter device 10with it as it is being backed out of the work site, which in turn, couldcause the wire guide 11, which is typically locked in place, to pull outof the coupling region 14. The stiffening stylet 103 is removed prior toor after the devices are uncoupled using radiographic, endoscopic,and/or proximally visible indicia located on the two devices 10,11.

While the gastrointestinal tract may at present provide the most obviousanatomical sites for practicing the methods and techniques of thepresent invention, further changes in interventional medicine may bringabout increasing opportunities where remote uncoupling and ultra-shortwire techniques may offer a viable alternative to traditional rapidexchange or other current techniques. For example, many commonurological procedures were preformed using wire guide exchange until theintroduction of videoendoscopes ideal for urological use. This resultedin direct visualization becoming the standard methodology formanipulating and placing devices in the urological tract. Futuredevelopments and improvement in external visualization methodology mayresult in a return to wire guided procedures where remote uncouplingoffers a true advantage to the urologist. Similar advancements in otherspecialties, especially in vascular and coronary medicine, may createsituations where the potential benefits of remotely uncoupling may berealized.

Any other undisclosed or incidental details of the construction orcomposition of the various elements of the disclosed embodiment of thepresent invention or methods of their use are not believed to becritical to the achievement of the advantages of the present invention,so long as the elements possess the attributes needed for them toperform as disclosed. The selection of these and other details ofconstruction are believed to be well within the ability of one of evenrudimentary skills in this area, in view of the present disclosure.Illustrative embodiments of the present invention have been described inconsiderable detail for the purpose of disclosing a practical, operativestructure whereby the invention may be practiced advantageously. Thedesigns and methods described herein are intended to be exemplary only.The novel characteristics of the invention may be incorporated in otherstructural forms without departing from the spirit and scope of theinvention. The invention encompasses embodiments both comprising andconsisting of the elements and steps described with reference to theillustrative embodiments. Unless otherwise indicated, all ordinary wordsand terms used herein shall take their customary meaning as defined inThe New Shorter Oxford English Dictionary, 1993 edition. All technicalterms shall take on their customary meaning as established by theappropriate technical discipline utilized by those normally skilled inthat particular art area. All medical terms shall take their meaning asdefined by Stedman's Medical Dictionary, 27th edition.

1. An elongate engagement member for use with an elongate medical devicecomprising tubular member having a coupling region configured to couplewith a wire guide, the coupling region being disposed near a distal endof the tubular member, wherein the elongate engagement member isconfigured to engage and releasably secure a wire guide coupled with theelongate medical device and prevent relative movement between the wireguide and the elongate medical device.
 2. The elongate engagement memberof claim 1, wherein the elongate engagement member comprises an elongateshaft, the elongate shaft having a distal end configured to frictionallyengage an exterior surface of the wire guide and an inner wall of apassageway within the tubular member.
 3. The elongate engagement memberof claim 2, wherein the distal end of the shaft is configured to engagea portion of the wire guide that is disposed within the passageway ofthe tubular member.
 4. The elongate engagement member of claim 2,wherein the elongate shaft further comprises a proximal end configuredto releasably engage with a proximal port of the elongate medicaldevice.
 5. The elongate engagement member of claim 2, wherein theelongate shaft comprises a plurality of shaft sections having differentphysical properties.
 6. The elongate engagement member of claim 5,wherein the plurality of shaft sections comprise a plurality ofmaterials.
 7. The elongate engagement member of claim 5, wherein theplurality of shaft sections comprise a plurality of cross-sectionalareas.
 8. The elongate engagement member of claim 2, wherein theelongate shaft comprises a taper having a decreasing cross-sectiontowards the distal end thereof.
 9. The elongate engagement member ofclaim 2, wherein the elongate shaft comprises a non-circularcross-section.
 10. The elongate engagement member of claim 9, whereinthe non-circular cross-section of the elongate shaft is configured toslidably extend through a correspondingly shaped passageway of thetubular member.
 11. The elongate engagement member of claim 2, whereinthe elongate shaft comprises a radiopaque marker disposed near thedistal end thereof.
 12. The elongate engagement member of claim 1,wherein the elongate engagement member comprises a tether, the tetherhaving a distal loop configured to wrap at least partially about thewire guide and apply a lateral force thereto that is sufficient to forcethe wire guide into frictional engagement with a portion of the tubularmember.
 13. The elongate engagement member of claim 12, wherein thetether is configured to pass through a passageway within the tubularmember of the elongate medical device.
 14. The elongate engagementmember of claim 13, wherein the tether further comprises a proximal endportion configured to releasably engage with a proximal port of theelongate medical device.
 15. The elongate engagement member of claim 1,wherein the elongate medical device comprises a first lumen, a secondlumen, and an internal wall disposed the first lumen and the secondlumen, further wherein the elongate engagement member comprises anelongate shaft configured to be disposed with the second lumen, theelongate shaft having a distal end portion configured to engage anddisplace the internal wall into the first lumen, the internal wall whenso displaced engaging an exterior surface of the wire guide.
 16. Theelongate engagement member of claim 15, wherein the second lumencomprises a decreasing cross-section along a portion thereof, thedecreasing cross-section being configured to for engagement with thedistal end portion of the elongate shaft, the engagement causingdisplacement of the internal wall into the first lumen.
 17. The elongateengagement member of claim 15, wherein the distal end portion of theelongate shaft comprises an expandable member for engaging anddisplacing the internal wall into the first lumen.
 18. A system forintroducing multiple medical devices into a work site within a bodilylumen of a patient comprising: an elongate medical device comprising atubular shaft extending between a distal end and a proximal end, a lumenextending through at least a portion of the tubular shaft, the lumencomprising a coupling region extending between a distal opening and aproximal opening; a wire guide comprising a shaft extending between adistal end and a proximal end, the shaft configure to slidably extendthrough the lumen of the elongate medical device; and an elongateengagement member, wherein the wire guide is movable from a coupledposition to an uncoupled position, the wire guide extending through thecoupling region of the elongated medical device when in the coupledposition, the wire guide not extending through the coupling region ofthe elongated medical device when in the uncoupled position, and whereinthe elongate engagement member is configured to engage and releasablysecure the wire guide in the coupled position and prevent relativemovement between the wire guide and the elongate medical device.
 19. Thesystem of claim 18, wherein the elongate engagement member comprises anelongate shaft, the elongate shaft having a distal end configured tofrictionally engage an exterior surface of the wire guide and an innerwall of the tubular shaft within the coupling region of the elongatemedical device.
 20. The system of claim 19, wherein the distal end ofthe shaft is configured to engage a portion of the wire guide that isdisposed within the lumen of the coupling region of the elongate medicaldevice.
 21. The system of claim 19, wherein the elongate shaft furthercomprises a proximal end configured to releasably engage with a proximalport of the elongate medical device, the proximal port being spacedapart from and proximal to the proximally opening.
 22. The system ofclaim 19, wherein the elongate shaft comprises a plurality of shaftsections having different physical properties.
 23. The system of claim22, wherein the plurality of shaft sections comprise a plurality ofmaterials.
 24. The system of claim 22, wherein the plurality of shaftsections comprise a plurality of cross-sectional areas.
 25. The systemof claim 19, wherein the elongate shaft comprises a taper having adecreasing cross-section towards the distal end thereof.
 26. The systemof claim 19, wherein the elongate shaft comprises a non-circularcross-section.
 27. The system of claim 26, wherein the lumen of theelongate medical device comprises a non-circular cross-section thatcorresponds with that of the elongate shaft.
 28. The system of claim 19,wherein the elongate shaft comprises a radiopaque marker disposed nearthe distal end thereof.
 29. The system of claim 18, wherein the elongateengagement member comprises a tether, the tether having a distal loopconfigured to wrap at least partially about the wire guide and apply alateral force thereto that is sufficient to force the wire guide intofrictional engagement with a portion of the tubular shaft of theelongate medical device.
 30. The system of claim 29, wherein the tetheris configured to pass through the lumen of the tubular shaft of theelongate medical device.
 31. The system of claim 30, wherein the tetherfurther comprises a proximal end portion configured to releasably engagewith a proximal port of the elongate medical device, the proximal portbeing spaced apart from and proximal to the proximally opening.
 32. Amethod of introducing multiple medical devices into a work site within abodily lumen of a patient, comprising the steps of: a. providing anelongate medical device comprising a tubular shaft having a distalportion, a proximal portion, and a lumen extending therethrough, thedistal portion comprising a coupling region; b. providing a wire guidecomprising a wire guide shaft extending between a distal end and aproximal end; c. providing an elongate engagement member having a distalend portion and proximal end portion; d. releasably coupling the wireguide to the elongate medical device by engaging the wire guide with thecoupling region of the elongate medical device; e. engaging the wireguide with the elongate engagement member so as to releasably secure thewire guide in the coupled position and prevent relative movement betweenthe wire guide and the elongate medical device; f. advancing theelongate medical device, the wire guide, and the elongate engagementmember to the work site.
 33. The method of claim 32, wherein elongateengagement member comprises an elongate shaft, and wherein the step ofengaging the wire guide with the elongate engagement member includes thestep of frictionally engaging a portion of the wire guide disposedwithin the coupling region of the elongate medical device with thedistal end portion of the shaft of the elongate engagement member. 34.The method of claim 32, wherein elongate engagement member comprises anelongate shaft, and wherein the step of engaging the wire guide with theelongate engagement member includes the step of distally advancing theshaft of the elongate engagement member through the lumen of theelongate medical device.
 35. The method of claim 32, wherein elongateengagement member comprises a tether having a loop on the distal endportion, and wherein the step of engaging the wire guide with theelongate engagement member includes the step of releasably engaging thewire guide with the loop of the elongate engagement member and applyinga lateral force thereto that is sufficient to force the wire guide intofrictional engagement with a portion of the tubular shaft.